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NS NY Distributor Inc Premium Orgazen 7000 and Ginseng Power 5000 capsules - recalled due to Undeclared Sildenafil and/or Tadalafil, USA

April 9, 2021 6:05 PM

United States

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 voluntarily 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

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

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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
See Less
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 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
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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
See Less
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

Covid-19 OSHA Complaint, Tesoro, 770 N. Grand Ave, PULLMAN, WA, 99163, USA

Tesoro, 770 N. Grand Ave, PULLMAN, WA, 99163, USA

May 9, 2021 12:00 PM

“Business not requiring masks.


Source: Osha.gov | Receipt Date: 2020-06-30 See Less
Reported By SafelyHQ.com User

Covid-19 OSHA Complaint, SHARIS OF NORTH YAKIMA, 1401 Lakeside Ct, YAKIMA, WA, 98902, USA

SHARIS OF NORTH YAKIMA, 1401 Lakeside Ct, YAKIMA, WA, 98902, USA

May 9, 2021 12:00 PM

“General Manager does not wear a mask inside of his office with the door closed and instructs me to come in with him and shut the door even if I try and stand outside. Assistant manager has pulled mask down to call out to kitchen workers, inches from my face. Workers wearing masks under their noses a... See Morend under their chins walk closely by me and talk with me in the kitchen and bakery area at the back of the restaurant. Cooks prepare food with masks below their chin and servers wear masks below the nose walking through the pass and through the bakery area. Off-duty employee walked from dining area to kitchen and bakery area and pulled down mask to socialize with staff.


Source: Osha.gov | Receipt Date: 2021-04-05
See Less
Reported By SafelyHQ.com User

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“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
See Less
Reported By SafelyHQ.com User

Pfizer BioNTech vaccine, Walgreens, Ohio 43, Streetsboro, OH, USA

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April 28, 2021 5:52 PM

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Symptoms after 27 hours: sore arm, joint and muscle pain, fatigue.... See MoreFeeling warm/flushed but no fever. See Less
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“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

Petmatrix Dreambone Dino Chews, Yulee, FL, USA

Symptoms: Vomiting Other
Yulee, FL, USA

April 27, 2021 9:13 AM

“We gave our dog the Dreambone Dino Chews on Sunday. On Tuesday we noticed he was wanting to go into his kennel and sleep. Tuesday evening he was acting odd with jerking movement, sticking his tongue out, oddly staring at the ceiling and refusing to drink water. We immediately took him to the vet whe... See Morere they induced vomiting, gave him antibiotics and an IV. He continued to not drink water in his own and show neurological behaviors that our vet said was focal seizures, lip-licking and star-gazing. The Dreambone treats were the only change in his diet. He would not drink water on his own for at least 3 days and he had focal seizures on and off for about 5 days. Do not give your dog any Petmatrix, Spectrum, or Dreambone product. They will poison your beloved pet. They package says they are made in China and when you google the company they are also made in Vietnam. See Less
Reported By SafelyHQ.com User
Doctor Visit: Yes
Diagnosis: Doctor visit

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

May 6, 2021 12:47 AM

“This was all after waiting the 20 minutes before leaving within 5 minutes after getting in my car I felt a burning in my right foot that within 20 minutes was burning both feet and legs all the way. Burning in my body from the waste down for 4 hours then severe rash all over my body except my face. See Less
Reported By SafelyHQ.com User

April 29, 2021 5:31 PM

“I ordered a "Battery-Powered Wood Cutter x 1". The picture of my order was very similar to the one next to this report I am making. They sent me an email back telling my they had two options on the page and I chose to pay for some chain looking thing that looks like you can kill someone with it. And... See Morethey refuse to give me my money back. I have the order, email correspondence and photos of the product I ordered. They advertise in very large photos one thing and then have a very small photo in the corner of something else. You had no idea was even there. Until you don't get what you ordered, but in stead you get the tiny thing in the corner. I can supply all this to you if you can stop these thieves from continuing there false business practices. See Less
Reported By SafelyHQ.com User

April 19, 2021 9:01 PM

“Company name: Tenacore LLC
Brand name: Tenacore LLC
Product recalled: 2001 Tenacore Replacement CareFusion Alaris 8100 bezels
Reason of the recall: Potentially weakened elastic
FDA Recall date: April 19, 2021
Recall details: Company Announcement On February 24th, 2021, Tenacore LLC initiated a... See Morenationwide recall of 2001 Tenacore replacement CareFusion Alaris 8100 bezels due to potentially weakened plastic. A bezel with weakened plastic may, over time, lead to separation of the bezel post (recall issue) as well as other damage to the bezel (e.g., external cracking). The separation of one or more bezel posts may result in free flow, over infusion, under infusion or interruption of infusion. There is a related recall initiated by Becton Dickinson (BD). Information regarding that recall can be found using the following link: Becton Dickinson (BD) (CareFusion 303, Inc.) Recalls Alaris Pump Module Model 8100 Bezel Assembly Which Could Result in Free Flow, Over-Infusion, Under-Infusion, or Interruption of Infusion | FDA Consumers who have: Tenacore bezel parts (part number TIPA-8100-4410) with timestamp 5 and/or timestamp 6 should stop the distribution and use of these and return them to Tenacore LLC.
Alaris 8100 units that were serviced by Tenacore, or purchased from Tenacore between July 2020 and Feb 2020, should be inspected per the instructions described below to ensure that your device is not impacted. If it is, please return your device to Tenacore LLC.
Recalled bezels were manufactured from May 2020 to June 2020 and distributed from July 2020 through Feb 2021. The following products have been recalled:
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User