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SCA Pharma Heparin Sodium Compounded products - recalled due to Incorrect preservative (benzyl alcohol), USA

August 18, 2020 7:00 PM

United States

Company name: SCA Pharmaceuticals
Brand name: SCA Pharma
Product recalled: Heparin Sodium Compounded products
Reason of the recall: Incorrect preservative (benzyl alcohol)
FDA Recall date: August 18, 2020
Recall details: Windsor, CT, SCA Pharmaceuticals (SCA) is voluntarily recalling 10 lots of Heparin Sodium to the hospital/user level. The compounded Heparin Sodium bag contains the undeclared preservative benzyl alcohol. The labelling listed methylparaben and propylparaben as preservatives; however, are not present in the product. SCA identified this labeling issue during the investigation of a low potency test result for Heparin Sodium (NDC 70004-0650-46).

Serious adverse reactions including fatal reactions and “gasping syndrome” are likely to occur in premature neonates and low-birth weight infants in the neonatal intensive care unit who receive benzyl alcohol as a preservative in infusion solutions, in any amount. Additional adverse reactions included gradual nervous system deterioration, seizures, bleeding in the skull, blood abnormalities, skin breakdown, liver and kidney failure, low blood pressure, slower than expected heart rate, and loss of sufficient brain blood flow to maintain consciousness.

Preterm, low-birth weight infants may be more likely to develop these reactions because they may be less able to metabolize benzyl alcohol. Furthermore, benzyl alcohol present in mother’s serum is likely to cross into human milk and may be orally absorbed by a nursing infant. For this reason, preservative-free heparin sodium injections is recommended when heparin therapy is needed during pregnancy. Benzyl alcohol is contraindicated in pediatric patients as well as pregnant or nursing women.

SCA has not received any complaints or reports of adverse events to date related to this recall. However, out of an abundance of caution, SCA is voluntarily recalling the lots listed herein. Heparin Sodium is used as an anticoagulant and is packaged in 500 mL or 1000 mL intravenous bags. Check the link below to see the full list of affected Heparin Sodium lots.

The compounded Heparin Sodium can be identified by checking the product name, concentration and lot number on the compounded bag. The compounded Heparin Sodium bags were distributed nationwide to hospitals.

SCA is notifying its customers by certified mail and is arranging for return of all recalled products. Hospitals that have compounded Heparin Sodium bags which are being recalled should stop using the product and return the product to SCA.

Consumers with questions regarding this recall can contact SCA by phone at 877-550-5059 or e-mail customerservice@scapharma.com between the hours of 7:00 am and 7:00 pm (Central Standard Time), Monday through Friday. 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.

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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December 23, 2020 10:00 PM

“Company name: Shane Erickson, Inc. DBA Innovative Marketing Consultants
Brand name: IMC
Product recalled: Wash-Free Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: December 23, 2020
Recall details: Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG:... See More2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml lot 2020/05/11 listed in the table below to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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 these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Shane Erickson, Inc. has not received any reports of adverse events related to the product(s) of this recall. Recalled Products:

- IMC Wash-Free Hand Sanitizer 50 ml, 1.7 oz (8 19845 00597 8). Lot: 43962. Expiration date: 45056
- IMC Wash-Free Hand Sanitizer 100 ml, 3.4 oz (8 19845 00598 5). Lot: MFG: 2020/05/10 L/N: 20200510-3. Expiration date: N/A
- IMC Wash-Free Hand Sanitizer | Wash-Free Hand Sanitizer | Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml, 10.14 oz (8 19845 00599 2). Lot: 43962. Expiration date: 45056

The product is used as a hand sanitizer for handwashing to decrease bacteria on the skin when soap and water are not available. All products are packaged in a plastic bottle. The 50 ml are in a HDPE opaque white bottle with a blue cap, the 100 ml is in a clear PET bottle with a clear cap and the 300 ml are in a clear PET bottle with a black pump. The product can be identified by checking the product size, UPC details, lot number and expiration date on the bottle containing the product. The product can also be identified by this information on the back label: Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, YUEWEIXIAOZHENGZI (2020) - 04 - No. 0023.

Some of the product has custom front labels (see examples below) the back label on the custom labels have the same identification information as previously mentioned above. The hand sanitizer was distributed Nationwide in the USA to wholesale and retail customers.

Shane Erickson, Inc. is notifying its distributors and customers by mail/email and is arranging for the return of all recalled products. Consumer, distributors, and retailers that have product, which is being recalled, should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Shane Erickson, Inc. by phone at 952.252.1254 [Call: 952.252.1254] or email sales@imcsuccess.com Monday through Friday from 8:00 am to 5:00 pm Central Time Zone.

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

December 28, 2020 8:00 PM

“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: December 28, 2020
Recall details: Schaumburg, Illinois, Sunstar Americas, I... See Morenc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall initially announced on October 27, 2020. 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, 29 adverse events have been reported to SAI related to this recall. Affected patients tested positive for Burkholderia lata infections, typically found in sputum cultures while under treatment for other serious medical conditions. Use of the contaminated product on patients with pre-existing respiratory conditions, including those infected with Covid-19, is particularly unsafe.

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 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 follow below:

-Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 16 fl.oz. Amber Bottles. NDC #: 052376-021-02. Product Code: 1789P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022

- Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% Size/ Form: 4 fl.oz. Amber Bottles NDC #: 052376-021-04. Product Code: 1788P. Lots Recalled: ALL LOTS with expiration date from Dec. 31, 2020 through Sep. 30, 2022.

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. Sunstar is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue. 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

January 1, 2021 9:01 PM

“Company name: Precision Dose Inc.
Brand name: GUM Paroex
Product recalled: Paroex Chlorhexidine Gluconate Oral Rinse, 15 mL unit dose cups
Reason of the recall: Potential contamination with Burkholderia lata
FDA Recall date: December 31, 2020
Recall details: Company Announcement Precision Dose,... See MoreInc. is voluntarily recalling all lots of Chlorhexidine Gluconate Oral Rinse USP, 0.12%, 15mL Unit Dose Cups bearing an expiration date from 1/31/2021 – 02/28/2022 (see specific lots below) to the consumer level. Precision Dose, Inc. was notified by the manufacturer of the product, Sunstar Americas, Inc., that this product may be contaminated with the bacteria Burkholderia lata.

From information provided by the manufacturer, Sunstar Americas, Inc., 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 pneumonia and bacteremia.

To date, no adverse events have been reported to Precision Dose, Inc. 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 the product impacted is:

- Distributed in cases each containing 3 shrink-wrapped plastic trays each with 10 unit dose cups, 30-pack. NDC 68094-028-62
- Distributed in cases each containing 10 shrink-wrapped plastic trays each with 10 unit dose cups, 100-pack. NDC 68094-028-61

Chlorhexidine Gluconate Oral Rinse was distributed nationwide in the USA to pharmaceutical wholesalers. Precision Dose, Inc. is notifying its consignees directly and is arranging for return of all recalled product. Patients, pharmacies, and healthcare facilities in possession of these products should stop using and dispensing immediately.

Consumers with questions regarding this recall can contact Precision Dose, Inc. at 1 (800) 397-9228 (Monday-Friday, 8:00 AM to 4:30 PM Central Time) or by email to customercare@precisiondose.com. Consumers should contact their physician or healthcare provider if they have experienced problems that may be related to using this drug product. Affected products and lot numbers follow below: AFFECTED LOTS-Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

January 4, 2021 11:00 AM

“Company name: Essaar Inc.
Brand name: Soho Fresh
Product recalled: 70% Rubbing Alcohol
Reason of the recall: Contaminated with Methanol
FDA Recall date: January 04, 2021
Recall details: Company Announcement Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol... See Morein 33.81 oz. clear plastic bottles to the consumer level. FDA analysis of the product revealed it is contaminated with methanol. 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 accidently ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning.

To date, Essar Inc. has not received any reports of adverse events related to this recall. The product is used as an external purpose use rubbing alcohol and is packaged in 33.81 oz. clear plastic bottles with lot number 200528303 and UPC 7502268987367.

Soho Fresh was distributed nationwide to retail stores. Essaar Inc. is notifying its distributors and customers by email and mail and is arranging for the return of all recalled product to Essaar Inc. Consumers that have product which is being recalled should stop using and discard or return to place of purchase or to Essaar Inc. contacting via email or phone or mailing address mentioned above for arrangements of return. Consumers who have purchased this product should not open the package or use the contents. Instead, they should return the product to the location of purchase for a full refund or call Essaar Inc. at 201-647-7606 Monday to Friday 9am to 5pm, Eastern Standard Time. Essaar Inc. can also be reached via email at essaarinc@yahoo.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. FDA’s update  

Check the full recall details on fda.gov

Source: FDA
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Reported By SafelyHQ.com User

January 4, 2021 9:01 PM

“Company name: Nostrum Laboratories
Brand name: Nostrum Laboratories
Product recalled: Metformin HCl Extended Release Tablets, USP 750 mg
Reason of the recall: NDMA exceeds acceptable daily intake limit
FDA Recall date: January 04, 2021
Recall details: Company Announcement Nostrum Laboratories... See More, Inc. is voluntarily recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) to the consumer level. The Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) have been found to contain levels of nitrosamine impurities above the ADI limit of 96 ng/day as published in the FDA Guidance Document issued September, 2020. This is an expansion of the recall initially announced on November 2, 2020. NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables. To date, Nostrum Laboratories, Inc. has not received any reports of adverse events related to this recall. The product is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus and is packaged in HDPE bottles of 100 tablets, under NDC 29033-056-01. The affected Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) lot is listed in the table below. The product can be identified as an off-white oblong tablet debossed with “NM7”. Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) was distributed Nationwide to wholesalers.
Check the full recall details on fda.gov
Source: FDA
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Reported By SafelyHQ.com User

January 8, 2021 6:01 PM

“Company name: Fresenius Kabi USA
Brand name: Fresenius Kabi
Product recalled: Ketorolac Tromethamine Injection, USP, 30 mg/mL
Reason of the recall: Presence of particulate matter
FDA Recall date: January 08, 2021
Recall details: Fresenius Kabi USA is voluntarily recalling a single lot of Ketoro... See Morelac Tromethamine Injection, USP, 30 mg/mL, 1 mL fill in a 2 mL amber vial to the user level due to the presence of particulate matter. Particulate matter was found in reserve sample vials. No adverse event reports have been received for the recalled lot, which was produced and sold in 2019.

Administration of products containing particulate matter could obstruct blood vessels and result in local irritation of blood vessels, swelling at the site of injection, a mass of tissue that could become inflamed and infected, blood clots traveling to the lung, scarring of the lung tissues, and allergic reactions that could lead to life-threatening consequences.

Ketorolac Tromethamine, a nonsteroidal anti-inflammatory drug, is indicated for the short-term (up to 5 days in adults) management of moderately severe acute pain that requires analgesia at the opioid level. The total combined duration of use of oral Ketorolac Tromethamine and Ketorolac Tromethamine Injection should not exceed 5 days. Listed below is a table of the recalled lot distributed nationwide in the United States to wholesalers, distributors, hospitals, and pharmacies between March 28, 2019 and September 3, 2019.

Product Name/Product size: Ketorolac Tromethamine Injection, USP, 30mg / mL, 1 mL fill in a 2 mL amber vial
NDC Number: 63323-162-01
Product Code: 160201
Batch Number: 6121083
Expiration Date: 02/2021
First Ship Date: 03/28/2019
Last Ship Date: 09/03/2019

Fresenius Kabi is notifying its distributors and customers by letter and asking customers and distributors to check their stock immediately and to quarantine and discontinue the use and distribution of any affected product. Distributors should notify their customers and direct them to quarantine and discontinue distributing or dispensing the affected lot, and to return the product to Fresenius Kabi.

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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January 16, 2021 3:36 PM

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I want what I was charged for!!! See Less
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Northern Lights Pizza - No masks, Northern Lights Pizza, Southwest 9th Street, Des Moines, IA, USA

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December 23, 2020 10:00 PM

“Company name: Shane Erickson, Inc. DBA Innovative Marketing Consultants
Brand name: IMC
Product recalled: Wash-Free Hand Sanitizer
Reason of the recall: Undeclared Methanol
FDA Recall date: December 23, 2020
Recall details: Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG:... See More2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml lot 2020/05/11 listed in the table below to the consumer level. The products are being recalled due to the potential presence of methanol (wood alcohol).

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 these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute, are most at risk for methanol poisoning. To date, Shane Erickson, Inc. has not received any reports of adverse events related to the product(s) of this recall. Recalled Products:

- IMC Wash-Free Hand Sanitizer 50 ml, 1.7 oz (8 19845 00597 8). Lot: 43962. Expiration date: 45056
- IMC Wash-Free Hand Sanitizer 100 ml, 3.4 oz (8 19845 00598 5). Lot: MFG: 2020/05/10 L/N: 20200510-3. Expiration date: N/A
- IMC Wash-Free Hand Sanitizer | Wash-Free Hand Sanitizer | Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml, 10.14 oz (8 19845 00599 2). Lot: 43962. Expiration date: 45056

The product is used as a hand sanitizer for handwashing to decrease bacteria on the skin when soap and water are not available. All products are packaged in a plastic bottle. The 50 ml are in a HDPE opaque white bottle with a blue cap, the 100 ml is in a clear PET bottle with a clear cap and the 300 ml are in a clear PET bottle with a black pump. The product can be identified by checking the product size, UPC details, lot number and expiration date on the bottle containing the product. The product can also be identified by this information on the back label: Made in China, Distributed by IMC 4284 Shoreline Dr, Spring Park, MN 55384, YUEWEIXIAOZHENGZI (2020) - 04 - No. 0023.

Some of the product has custom front labels (see examples below) the back label on the custom labels have the same identification information as previously mentioned above. The hand sanitizer was distributed Nationwide in the USA to wholesale and retail customers.

Shane Erickson, Inc. is notifying its distributors and customers by mail/email and is arranging for the return of all recalled products. Consumer, distributors, and retailers that have product, which is being recalled, should stop use or distribution and return to place of purchase. Consumers with questions regarding this recall can contact Shane Erickson, Inc. by phone at 952.252.1254 [Call: 952.252.1254] or email sales@imcsuccess.com Monday through Friday from 8:00 am to 5:00 pm Central Time Zone.

Check the full recall details on fda.gov

Source: FDA
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Pet owners should stop feeding their pets the recalled products listed below and consult their veterinarian, especially if the pet is showing signs of illness. The pet owner should remove the food and make sure no other animals have access to the recalled product. Sanitize pet food bowls, scoops, and storage containers using bleach, rinsing well afterwards with water, and drying thoroughly. There is no evidence to suggest that pet owners who handle products containing aflatoxin are at risk of aflatoxin poisoning.

Midwest Pet Food, Inc. already recalled the following lots of Sportmix pet food products:
- Sportmix Energy Plus, 50 lb. bag. Lots: Exp 03/02/22/05/L2 | Exp 03/02/22/05/L3 | Exp 03/03/22/05/L2
- Sportmix Energy Plus, 44 lb. bag. Lot: Exp 03/02/22/05/L3
- Sportmix Premium High Energy, 50 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Premium High Energy, 44 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 31 lb. bag. Lot: Exp 03/03/22/05/L3
- Sportmix Original Cat, 15 lb. bag. Lots: Exp 03/03/22/05/L2 | Exp 03/03/22/05/L3

Check the full outbreak announcement on fda.gov

Source: FDA
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