Drug Recalls
A drug recall is one of the most effective ways to protect consumers from a defective or potentially harmful medicine. A recall is a voluntary action taken by a company to remove a defective drug from the market or warn patients and consumers about a potential risk.
More Information on Drug Recalls
- Visit the Drug recall information for consumers, health care professionals and industry page for information on the drug recall process.
- Visit Recalls, Market Withdrawals, & Safety Alerts for all FDA-regulated products.
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Drug Recall Announcements by Company
| Date | Brand Name(s) | Product Description | Recall Reason Description | Company Name | Terminated Recall | Excerpt |
|---|---|---|---|---|---|---|
| Par Health and Endo USA | Argatroban Injection 250 mg/2.5 mL (100 mg/mL) | Presence of particulate matter, identified as cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel | Par Health USA, LLC | |||
| Par Pharmaceutical | Brevital Sodium 500 mg/vial for Injection | Presence of particulate matter identified as cellulose | Par Health | |||
| Greenwich | Glutathione Injection | Potential elevated endotoxin levels | Greenwich Rx | |||
| ICU Medical LLC | 0.9% Sodium Chloride Injection, USP, 100 mL | Product mix-up where 0.9% Sodium Chloride Injection, USP overwrap may contain 10 mEq Potassium Chloride Injection | Otsuka ICU Medical LLC | |||
| Par Pharmaceutical | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection 400 mcg/100 mL (4 mcg/mL) for Intravenous Infusion | Presence of particulate matter identified as cellulose or stopper material | Par Health | |||
| Niwali | Tejocote Capsules and Pieces | Products contain yellow oleander (Thevetia peruviana). | Global Mix Inc. | |||
| Centric Compounding | Compounded Glutathione 200 mg/mL 30 mL multidose vial; Myer’s Cocktail 30 mL multidose vial; Tri-Immune Boost 30 mL multidose vial | Elevated Endotoxin level | Centric Compounding LLC | |||
| B. Braun | 0.9% Sodium Chloride Injection USP, 100 mL, in a 150 mL PAB® Container | Presence of particulate matter identified as iron oxide | B. Braun Medical Inc. | |||
| American Regent, Inc. | Epinephrine Injection, USP 30 mg/ 30 mL (1 mg/mL) multi dose vial | Presence of particulate matter and lack of sterility assurance | American Regent, Inc. | |||
| Lipofit | Lipofit Extreme 2.0 Fat Burner Dietary Supplement | Undeclared Fluoxetine and 2,4-Dinitrophenol (DNP) | Ana Salazar Modela Tu Cuerpo Inc. |