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  1. Drug Safety and Availability

Drug Recalls

A drug recall is the most effective way to protect the public from a defective or potentially harmful product. A recall is a voluntary action taken by a company to remove a defective drug product from the market or warn patients and consumers about a potential risk.

The list below includes voluntary drug recalls in which public notification has been issued.

Visit FDA’s role in drug recalls for more information.
Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
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A Terminated Recall is a recall where the FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard. Recalls that are not indicated as being terminated are either ongoing or completed.

Date Brand Name(s) Product Description Recall Reason Description Company Name Terminated Recall Excerpt
Amneal Pharmaceuticals LLC. Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag Product may contain an inert fiber identified as polypropylene fibers from the IV bag Amneal Pharmaceuticals LLC.
CAPS Phenylephrine 40 mg added to 0.9% Sodium Chloride 250 mL in 250 mL Excel Bag Due to visible black particulate matter CAPS
SinuCleanse Soft Tip Squeeze Bottle Nasal Wash System Microbial contamination of the product with Staphylococcus aureus (S. aureus) Ascent Consumer Products Inc.
Vitality Vitality male enhancement dietary supplement capsules Undeclared Sildenafil and Tadalafil One Source Nutrition
BD ChloraPrep Clear 1 mL applicator skin preparation product Potential for fungal contamination under certain environmental conditions allowing the growth of Aspergillus penicillioides BD
ICU Medical POTASSIUM CHLORIDE Inj. 20 mEq and 10 mEq Bags of POTASSIUM CHLORIDE Inj. 20 mEq have incorrect overwrap labels which state POTASSIUM CHLORIDE Inj. 10 mEq. ICU Medical
Alvogen Fentanyl Transdermal System 25 mcg/h transdermal patches There is potential that patches could be multi-stacked, adhered one on top of the other, in a single product pouch Alvogen, Inc.
Provepharm Inc. Phenylephrine hydrochloride Injection, USP, 10 mg/ mL Device & Drug Safety – Potential Foreign Material Provepharm Inc.
Astellas Tacrolimus and Tacrolimus Extended-Release capsules Bottles may contain empty capsules. Astellas Pharma US, Inc.
Systane Lubricant Eye Drugs Due to Fungal Contamination Alcon Laboratories
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