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Alerts and Recalls

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  • Lorazepam Oral Concentrate, USP 2mg/mL by Amneal Pharmaceuticals: Recall - Misprinted Dosing Droppers

    Wednesday, August 16, 2017
    Amneal Pharmaceuticals LLC is voluntarily recalling 13 lots of Lorazepam Oral Concentrate, USP 2mg/mL, to the Consumer level due to a defect in the dropper markings. The Lorazepam Oral Concentrate, USP 2mg/mL, product is packaged with a dosing dropper, supplied to Amneal by a third party.

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  • Pravastatin Sodium Tablets by International Laboratories: Recall - Mislabeling

    Friday, August 11, 2017
    International Laboratories, LLC is voluntarily recalling one (1) Lot of Pravastatin Sodium Tablets USP 40 mg packaged in bottles of 30 tablets, to the consumer level due to mislabeling. The product is labeled as Pravastatin Sodium Tablets USP 40 mg but contained Bupropion Hydrochloride XL 300 mg...

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  • Liquid Drug Products Manufactured by PharmaTech and Distributed by Rugby Laboratories and Possibly Other Companies: FDA Advisory - Not to Use

    Thursday, August 10, 2017
    FDA is advising health care professionals and patients not to use any liquid product manufactured by PharmaTech LLC, Davie, Florida, due to Burkholderia cepacia contamination and the potential for severe patient infection. Rugby Laboratories, Livonia, Michigan, announced a voluntary recall on...

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  • Increase in Reported cases of Cyclospora cayetanensis Infection, United States, Summer 2017

    Monday, August 7, 2017
    The Centers for Disease Control and Prevention (CDC), State and Local Health Departments, and the Food and Drug Administration (FDA) are investigating an increase in reported cases of cyclosporiasis. The purpose of this HAN Advisory is to notify public health departments and healthcare facilities...

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  • Diocto Liquid and Diocto Syrup by Rugby Laboratories: Recall - Possible Product Contamination

    Thursday, August 3, 2017
    Rugby Laboratories is voluntarily recalling all lots of Diocto Liquid and Diocto Syrup, (docusate sodium solutions) manufactured by PharmaTech, LLC due to a risk of product contamination with Burkholderia cepacia. FDA informed Rugby that it received several adverse event reports of B. cepacia...

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  • 0.9% Sodium Chloride Injection by ICU Medical: Recall

    Monday, July 31, 2017
    ICU Medical, Inc. is voluntarily recalling one lot of 0.9% Sodium Chloride Injection, USP 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Injection of particulate matter could...

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  • Apace Packaging LLC Issues Voluntary Nationwide Recall of Cyclobenzaprine HCL and Amantadine HCL (Lot 16710) Due to Potential Mislabeling

    Friday, July 28, 2017
    Apace Packaging LLC is voluntarily recalling one lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710 and one lot of Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 to the Retail level. These products have been...

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  • Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance

    Wednesday, July 26, 2017
    Cantrell Drug Company is voluntarily recalling all lots of unexpired sterile drug products to the hospital and user level due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide, except to the states of Connecticut, Hawaii, South Carolina and...

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  • Novo Nordisk Recalls Cartridge Holders In Certain Novopen Echo® Insulin Delivery Devices Due to Potential Health Risks

    Thursday, July 6, 2017

    Novo Nordisk is initiating a recall of insulin cartridge holders used in a small number of NovoPen Echo® batches because they may crack or break if exposed to certain chemicals, like certain cleaning agents. NovoPen Echo® is used for insulin treatment by people with diabetes. Using a device with a cracked/broken cartridge holder may result in the device delivering a reduced dose of insulin which could potentially lead to high blood sugar. Novo Nordisk believes the risk of experiencing high blood sugar when using a device with an affected cartridge holder is low.

    For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click here.

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  • FDA Med Watch: Clindamycin Injection ADD - Vantage Vials by Alvogen - Recall: Lack of Sterility Assurance

    Monday, June 19, 2017

    Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira Inc., a Pfizer Company.

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