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Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz - recalled due to potential contamination with Burkholderia lata, USA

October 28, 2020 11:00 AM

United States

Company name: Sunstar Americas, Inc.
Brand name: Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 4 oz and 16 oz
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: October 28, 2020
Recall details: Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 6/30/22 – 9/30/22 (see specific lots below) to the consumer level. This product may be contaminated with the bacteria Burkholderia lata.

Use of the defective product in the immunocompetent host may result in oral and, potentially, systemic infections requiring antibacterial therapy. In the most at-risk populations, the use of the defective product may result in life-threatening infections, such as pneumonia and bacteremia. To date, no adverse events have been reported to SAI related to this recall. The prescription oral rinse product, available through healthcare professionals only, is indicated for use as part of a professional program for the treatment of gingivitis and is packaged as follows:

- 1789P GUM® Paroex® is distributed in cases each containing 6 amber bottles of 16 fluid ounce (473 ml) chlorhexidine rinse. The bottle has a childproof cap and a 15 ml metered dosage cup, is safety sealed, and is decorated with a multiple-panel wrap-around label.
- 1788P GUM® Paroex® is distributed in cases each containing 24 amber bottles of 4 fluid ounce (118.25 ml) chlorhexidine rinse. The bottle has a childproof cap, is safety sealed, and is decorated with a multiple-panel wrap-around label.

The product can be identified by as shown in the images below: Paroex was distributed Nationwide to Dental offices, Dental distributors, Pharmaceutical wholesalers, Dental schools, and Pharmacies. SAI is notifying its direct distributors and customers by USPS Priority mail and is arranging for return of all recalled products. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact SAI by phone at 1-800-528-8537 or email us.pcr@us.sunstar.com on Monday-Friday from 8am-5pm CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this drug product. Affected products and lot numbers are detailed in the link below.

Check the full recall details on fda.gov

Source: FDA

Reported By SafelyHQ.com User
More incidents from:
Drugs
United States

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April 5, 2021 5:00 PM

“Company name: QMART
Brand name: IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 05, 2021
Recall det... See Moreails: Company Announcement Elmwood Park, NJ, QMART is voluntarily recalling all lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 to the consumer level. FDA analysis has found the products to be tainted with undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are ingredients known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 renders them unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. Risk Statement: Consumers with underlying medical issues who take IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 capsules with undeclared sildenafil and/or tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, QMART has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual performance enhancement and are packaged in cardboard blisters. The affected lots of IMPERIAL Gold 2000, PremierZEN Extreme 3000, BURRO en PRIMAVERA 60000 & IMPERIAL Platinum 2000 include all lots. The product can be identified by the UPC codes in the table below which were distributed via internet and fulfilled by amazon at www.amazon.com. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
Check the full recall details on fda.gov
Source: FDA
See Less
Reported By SafelyHQ.com User

April 6, 2021 5:00 PM

“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Company Announcement Cli... See Moreffside Park, NJ, Yolo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction. The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall.

Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE- 5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.

Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 7, 2021 11:00 AM

“Company name: Yolo Studio
Brand name: PremierZEN Extreme 3000, PremierZEN Plus 5000, & Triple SupremeZEN Plus 3500
Product recalled: Dietary Supplement for male sexual enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: April 06, 2021
Recall details: Cliffside Park, NJ, Yol... See Moreo Studio is voluntarily recalling all lots of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil. Tadalafil is ingredient known as a phosphodiesterase (PDE-5) inhibitor found in FDA approved products for the treatment of male erectile dysfunction.

The presence of tadalafil in PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 makes these unapproved new drugs for which the safety and efficacy have not been established and, therefore subject to recall. Consumers with underlying medical issues who take PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 with undeclared tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening.

Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, Yolo Studio has not received any reports of adverse events related to this recall. These tainted products are marketed as dietary supplements for male sexual enhancement and are packaged in cardboard blisters containing one pill per card.

The affected lot numbers of PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 include all lots. PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 were distributed via internet and fulfilled by amazon at www.amazon.com nationwide in the USA. On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients.

It also encouraged online marketplaces to ensure these products are not sold on their platforms. Yolo Studio is notifying its customers by this press announcement and via e-mail of this recall. Consumers that have PremierZEN Extreme 3000, PremierZEN Black 5000, & Triple SupremeZEN Plus 3500 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact Yolo Studio by phone at (201) 233-3521 Monday through Friday from 9am to 5pm eastern time zone or e-mail yolostudiodamazon@gmail.com.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 9, 2021 6:05 PM

“Company name: NS NY Distributor Inc
Brand name: NS NY Distributor Inc
Product recalled: Premium Orgazen 7000 and Ginseng Power 5000 capsules
Reason of the recall: Undeclared Sildenafil and/or Tadalafil
FDA Recall date: April 09, 2021
Recall details: Company Announcement NS NY Distributor Inc is... See Morevoluntarily recalling all lots within expiry of Premium Orgazen 7000 and Ginseng Power 5000 capsules to the consumer level. FDA  analyses has found the products to contain undeclared sildenafil and/or tadalafil. Sildenafil and tadalafil are known as phosphodiesterase (PDE-5) inhibitors found in FDA approved products for the treatment of male erectile dysfunction. The presence of sildenafil and/or tadalafil in Premium OrgaZen 7000 and Ginseng Power 5000 makes them unapproved new drugs for which the safety and efficacy have not been established and therefore subject to recall.

Consumers with underlying medical issues who take Premium OrgaZen 7000 capsules and Ginseng Power 5000 with undeclared sildenafil and/or tadalafil may experience serious health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. To date, NS NY Distributor Inc has not received any reports of adverse events related to this recall.

These tainted products are marketed as a dietary supplements for male sexual enhancement and are packaged in a single capsule blister foil sheet and sold in lots of 3 capsules, 5 capsules and 10 capsules. The affected lot numbers of Premium OrgaZen 7000, UPC 0 40232 18144 3, and Ginseng Power 5000, UPC 0 40232 18144 3 include all lots. Premium OrgaZen 7000 and Ginseng Power 5000 were distributed nationwide in the USA via the internet by seller account Beauty.Kor. and fulfilled by amazon at www.amazon.com.

NS NY Distributor Inc is notifying customers who purchased through Amazon seller account Beauty.Kor by this press announcement. Consumers that have Premium OrgaZen 7000 and Ginseng Power 5000 which are being recalled should stop using and destroy them. Consumers with questions regarding this recall can contact NS NY Distributors Inc by email at NSNYdistributors@gmail.com.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

- Complete and submit the report Online.
- Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 28, 2021 7:00 PM

“Company name: Scentsational Soaps & Candles, Inc.
Brand name: Ulta Beauty Collection & SS
Product recalled: Scented Hand Sanitizer
Reason of the recall: Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde
FDA Recall date: April 28, 2021
Recall details: Scentsational Soaps & Candles, I... See Morenc., is voluntarily recalling 5 lots of Scentsational Soaps & Candles scented Hand Sanitizers from the Black and White Collection and Photo Real Collection and 3 lots of Ulta Beauty Collection scented Hand Sanitizer Spray packaged in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer level. See products listed in the table below.

These products are being recalled after testing conducted by our firm revealed the presence of methanol (wood alcohol), benzene, and acetaldehyde. These products were distributed nationwide in the USA through Ulta Beauty, TJ Maxx, and Marshalls retail stores.

Risk Statement: Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system, or death. Although all persons using these products on their hands are at risk, young children who accidentally ingest the products and adolescents and adults who drink the products as an alcohol (ethanol) substitute are most at risk for methanol poisoning. Exposure to benzene can occur through inhalation, oral, and skin.

There is a reasonable probability that benzene present at levels above the maximum daily exposure recommendations can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life-threatening. Additionally, animal studies have shown that acetaldehyde can possibly cause cancer in humans.

To date, the company has not received any reports of adverse reactions related to this recall. These products are used as hand sanitizers and marketed to help decrease bacteria on the skin when soap and water are not available. The affected bottles of hand sanitizer include a five-digit lot code printed on the bottle near the base or, in the case of the Ulta Beauty Collection product, a five-digit lot code followed by a single letter. The products can be identified by the label, scent, and lot code provided in the table at the end of this release. Photos are also attached to this notice.

Scentsational Soaps & Candles, Inc., has notified its direct customers by telephone with confirmatory email and asked that they remove the recalled products from commerce immediately if they still had any in inventory. Consumers, distributors and retailers that have the hand sanitizers which are being recalled should stop using, distributing and/or selling them and return them to the place of purchase.

Ulta Beauty has confirmed it has removed the recalled Ulta Beauty Collection product from its stores and online. Consumers with questions regarding this recall can contact our Customer Support Desk, 1-855-554-8050, M-F, during business hours 9:00 a.m. – 5:00 p.m. ET.

Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. “As the owners of the company, my wife and I want to reassure consumers and our customers that we are doing absolutely everything possible to carry out this recall efficiently and effectively and ensure it does not happen again.” said Steve Morrison of Scentsational Soaps & Candles, Inc.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

April 30, 2021 6:01 PM

“Company name: Acella Pharmaceuticals, LLC
Brand name: Acella
Product recalled: NP Thyroid (Thyroid Tablets, USP)
Reason of the recall: Sub potency
FDA Recall date: April 30, 2021
Recall details: Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 belo... See Morew of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations, or cardiac arrhythmia.

To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count and 7-count bottles. See product images below. To best identify the product, the NDC’s, Product Description, Lot Numbers, and Expiration Dates are listed on the link below.

These lots were distributed nationwide in the United States to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

May 4, 2021 9:01 PM

“Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial
Reason of the recall: Due to visible particulate
FDA Recall date: May 04, 2021
Recall details: Hospira, Inc., a Pfizer company, is voluntarily recallin... See Moreg lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.

Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever,    gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

The NDC, Lot Number, Expiration Date, and Configuration details for Sterile Water for Injection, USP, is indicated in the table below and a photo of the product can be found at the end of this press release. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020.

- Sterile Water for Injection, USP 100 mLbr Single-dose Glass Fliptop Vial. NDC: Vial: 0409-4887-25 | Carton: 0409-4887-99. Lot Number: DN9185. Expiration Date. 01 Apr 2023. Presentation: 100 mL, Single-dose Glass Fliptop Vial. Configuration: Tray of 25 vials.

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product.

Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the information in the link below.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 4, 2021 9:01 PM

“Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and 1% Lidocaine HCl Injection, USP 30 mL
Reason of the recall: Due to mislabeling
FDA Recall date: May 04, 2021
Recall details: Hospira, Inc., a Pfizer company, is volun... See Moretarily recalling lot EG6023 of 0.5% Bupivacaine Hydrochloride Injection, USP 30 mL and lot EG8933 of 1% Lidocaine HCl Injection, USP 30 mL, to the hospital/institution level due to mislabeling whereby a portion of each lot was incorrectly labeled as the other product. This issue was identified as part of the investigation of a confirmed customer report.

Hospira’s assessment of the potential risk to patients concluded that the use of the impacted product is likely to cause adverse events of moderate to high severity. If 1% lidocaine is administered to the patient instead of 0.5% bupivacaine, the patient may be underdosed, leading to lack of efficacy with potential outcomes such as inadequate pain management, and failure of surgical anesthesia. If 0.5% bupivacaine is administered to the patient instead of 1% lidocaine, an overdose of bupivacaine may occur, which could lead to potential outcomes such as seizures; respiratory abnormalities including low oxygen and/or elevated carbon dioxide in the blood, too much acid in the body fluids, and temporary cessation of breathing; heart abnormalities such as heart contraction and/or relaxation issues, irregular heartbeat, slower than normal heart rate, abnormal heart rhythm in which the ventricles of the heart quiver instead of pumping normally, cardiac arrest and cardiac flatline.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots. 0.5% Bupivacaine Hydrochloride Injection, USP is indicated in adults for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and obstetrical procedures. 1% Lidocaine HCl Injection, USP is indicated for the production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks when the accepted procedures for these techniques as described in standard textbooks are observed.

The NDC, Lot Number, Expiration Date, Strength and Configuration details for 0.5% Bupivacaine Hydrochloride Injection, USP and 1% Lidocaine HCl Injection, USP are in the table below and a photo of the products can be found at the end of this press release. The product lots were distributed nationwide to wholesalers, distributors, retailers, and hospitals in the United States, Puerto Rico and Guam from December 29, 2020 to April 15, 2021.

- 0.5% Bupivacaine Hydrochloride Injection, USP, Single Dose Teartop Vial. NDC: Vial: 0409-1162-19 Tray: 0409-1162-02. Lot number: EG6023. Expiration Date: 01 July 2022. Strength: 0.5%, 150 mg/30 mL (5 mg/mL). Configuration/ Count: Case Pack 2 x 25 Vials.
- 1% Lidocaine HCl Injection, USP Single Dose Teartop Vial. NDC: Vial: 0409-4279-16 Tray: 0409-4279-02. Lot number: EG8933. Expiration Date: 01 Aug 2022. Strength: 1%, 300 mg/30 mL (10 mg/mL). Configuration/ Count: Case Pack 2 x 25 Vials.

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers, distributors, retailers, and hospitals by mail to arrange for return of any recalled product.

Wholesalers, distributors or retailers with an existing inventory of the lot, which is being recalled, should stop administration and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or retail level, please notify any accounts or additional locations which may have received the recalled product from you.

Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Check the full recall details on fda.gov

Source: FDA
See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, INVESTMENTS BY DESIGN LLC, 3248 E Jump Off Rd Frnt, VALLEY, WA, 99181, USA

INVESTMENTS BY DESIGN LLC, 3248 E Jump Off Rd Frnt, VALLEY, WA, 99181, USA

May 9, 2021 12:00 PM

“Employer not wearing a mask or 6ft social distance rule after having covid.


Source: Osha.gov | Receipt Date: 2021-03-10 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, Eastern Washington University - Payroll Office, 526 5th Street, Cheney, WA 99004, USA

Eastern Washington University - Payroll Office, 526 5th Street, Cheney, WA 99004, USA

May 9, 2021 12:00 PM

“Management is directing low-level employees to enter a Covid-19 testing area without proper PPE and proper training. The only thing they are providing is a pair of gloves and disposable mask. Five facility employee's works in the area. They are not doing temperature check or screening.


Source:... See MoreOsha.gov | Receipt Date: 2021-03-09 See Less
Reported By SafelyHQ.com User

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Reported By SafelyHQ.com User

May 4, 2021 9:01 PM

“Company name: Hospira, Inc.
Brand name: Hospira, Inc.
Product recalled: Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial
Reason of the recall: Due to visible particulate
FDA Recall date: May 04, 2021
Recall details: Hospira, Inc., a Pfizer company, is voluntarily recallin... See Moreg lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.

Hospira’s assessment of the potential risk to patients concluded that in rare instances the use of the impacted product can be associated with potential adverse events such as anaphylaxis, fever,    gastrointestinal disturbances, vein irritation, localized vein inflammation, phlebitis, end-organ granuloma, tissue ischemia, pulmonary emboli, and infarction.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for this lot. Sterile Water for Injection USP is a sterile, nonpyrogenic preparation of water for injection which contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers. This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.

The NDC, Lot Number, Expiration Date, and Configuration details for Sterile Water for Injection, USP, is indicated in the table below and a photo of the product can be found at the end of this press release. The product lot was distributed nationwide to wholesalers/distributors/and hospitals in the United States from October to December 2020.

- Sterile Water for Injection, USP 100 mLbr Single-dose Glass Fliptop Vial. NDC: Vial: 0409-4887-25 | Carton: 0409-4887-99. Lot Number: DN9185. Expiration Date. 01 Apr 2023. Presentation: 100 mL, Single-dose Glass Fliptop Vial. Configuration: Tray of 25 vials.

Hospira, Inc., places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process. Hospira, Inc. has notified wholesalers/ distributors/hospitals by letter to arrange for return of any recalled product.

Wholesalers, distributors or hospitals with an existing inventory of the lot, which is being recalled, should stop use and distribution and quarantine immediately. If you have further distributed the recalled product, to the wholesale or hospital level/institution, please notify any accounts or additional locations which may have received the recalled product from you. Hospitals/Institutions should inform Healthcare Professionals in your organization of this recall. For additional assistance, call Stericycle at 1-800-805-3093 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the information in the link below.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

April 12, 2021 1:00 PM

“Company name: J. M. Smucker Co.
Brand name: Meow Mix®
Product recalled: Meow Mix® Original Choice Dry Cat Food
Reason of the recall: Potential Salmonella Contamination
FDA Recall date: April 12, 2021
Recall details: Orrville, OH – The J. M. Smucker Co. today announced a limited, voluntary recal... See Morel of two lots of Meow Mix® Original Choice Dry Cat Food (30LB bag) due to potential salmonella contamination. The Company has received no reports of pet illness or adverse reaction and has issued this recall out of an abundance of caution.

The impacted products were sold at select Walmart stores in IL, MO, NE, NM, OK, UT, WI, and WY. No other Meow Mix® products are impacted by this recall. If pet parents have products matching the following description in their possession, they should stop feeding it to their cats and dispose of it immediately. This information can be found on the bottom and back of each bag.

- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1081804. Best If Used By Date: 9/14/2022
- Meow Mix® Original Choice Dry Cat Food (30 LB Bag). Retail UPC Code: 2927452099. Lot Code: 1082804. Best If Used By Date: 9/15/2022

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

May 4, 2021 11:48 PM

“I was sent a comando chain instead this company is a fraud and PayPal let it happen 😡😡😡🤦🏽‍♀️🤬 See Less
Reported By SafelyHQ.com User

2nd Dose Pfizer Vaccine, Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

Symptoms: Nausea Headache Dizziness Fatigue Body Ache Soreness
Parkland Hospital, Harry Hines Boulevard, Dallas, TX, USA

April 21, 2021 6:01 PM

“Day 1 after vaccination my symptoms were a headache, nausea, medicine head, dizzy spells and alittle fatigue. Day 2 after my second dose. My symptoms include the following, sore painful arm, nausea, slight headache, medicine head, body & muscle aches, lymph nodes appeared to be inflamed which caused... See Moremy ears to hurt. Felt like I had a mild case of the flu. Been miserable and missing 2 days of work because of this. See Less
Reported By SafelyHQ.com User

SCAM, Alameda, CA, USA

Alameda, CA, USA

May 4, 2021 2:10 PM

“I bought a battery powered woodcutting saw from Kenyak. I recieved a chain with two rings. How can we stop these people. I bought this a couple months ago and today the ad is still running on USA today. Please help. Please stop these people. The add is still on USA today See Less
Reported By SafelyHQ.com User

April 30, 2021 3:56 PM

“The same still saw scam as the other people on here. Same ad. It states $19.99 for that day and I ordered it. I also got the little manual wire saw. It said saw and accessories. It really hurts people on a fixed income. I hope they are proud of themselve See Less
Reported By SafelyHQ.com User

April 22, 2021 10:09 AM

“Yes. I also ordered the GTA 26 battery-powered electric chainsaw. I got the chain with handles. I was bantering back and forth with Chinese agent, who really does not know what to do except to try and get more money from me for an inferior chainsaw for $6. I ordered a GTA 26 chainsaw, Stihl brand. I... See Moregot the hand chainsaw (had never heard of using a chain by hand, but it is an actual thing). I don't think you can convert the hand chainsaw to using it with an actual chain saw anyway. The Chinese agent is trying appease me by saying I can get a chainsaw to use with the chain for $60. The website he sent me show a completely different chainsaw for 29.99 and he sent the actual picture of the See Less
Reported By SafelyHQ.com User

April 21, 2021 12:38 PM

“Blackcass.com is a total scam. My wife bought me what she thought was a mini electric chain saw. The site showed a sthil chain saw for $29.99 instead of $59.99. Not knowing the prices on tools she thought to surprise me. The next day I found her order in our computer and immediately contacted them a... See Morend tried to cancel it. They said it was too late as the order had already been processed. 10 weeks later we got a hand rose clipper instead. My wife had paid $37.99 for a clipper I got at Ace hardware before for $9.99 See Less
Reported By SafelyHQ.com User

April 30, 2021 6:01 PM

“Company name: Acella Pharmaceuticals, LLC
Brand name: Acella
Product recalled: NP Thyroid (Thyroid Tablets, USP)
Reason of the recall: Sub potency
FDA Recall date: April 30, 2021
Recall details: Acella Pharmaceuticals, LLC, is voluntarily recalling certain lots listed in the Tables 1 and 2 belo... See Morew of 15-mg, 30-mg, 60-mg, 90-mg and 120-mg NP Thyroid®, Thyroid Tablets, USP [levothyroxine (T4) and liothyronine (T3)] to the consumer level. The products are being recalled because routine testing has found these lots to be sub potent. The product contains less than 90% of the labeled amount of liothyronine (T3) and/or levothyroxine (T4).

Risk Statement: Patients being treated for hypothyroidism (underactive thyroid), who receive sub potent NP Thyroid®, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight.

There is reasonable risk of serious injury in newborn infants or pregnant women with hypothyroidism including early miscarriage, fetal hyperthyroidism, and/or impairments to fetal neural and skeletal development. In elderly patients and patients with underlying cardiac disease toxic cardiac manifestations of hyperthyroidism may occur, such as cardiac pain, palpitations, or cardiac arrhythmia.

To date, Acella has received 43 reports of serious adverse events that could possibly be related to this recall. NP Thyroid®, Thyroid Tablets, USP is composed of levothyroxine and liothyronine, and used to treat hypothyroidism (underactive thyroid). The products subject to recall are packed in 100-count and 7-count bottles. See product images below. To best identify the product, the NDC’s, Product Description, Lot Numbers, and Expiration Dates are listed on the link below.

These lots were distributed nationwide in the United States to Acella’s direct accounts, including wholesalers, pharmacies, and healthcare offices. Acella is proactively notifying its consignees to discontinue distribution of the above referenced lots being recalled and is arranging for return of all recalled products. Patients who are currently taking NP Thyroid® from the lots being recalled should not discontinue use without contacting their healthcare provider for further guidance and/or a replacement prescription.

Consumers with questions about the recall can email Acella Pharmaceuticals at recall@acellapharma.com or contact our representatives at 1-888-424-4341, Monday through Friday from 8:00 am – 5:00 pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User