Drug Safety Alerts

Amikacin Sulfate Injection Class I Recall

06/01/2016


On June 1, 2016, the United States Food and Drug Administration (FDA) issued a Class I Recall on amikacin sulfate injection 1 gram/4 mL (250 mg/mL) manufactured by Teva Pharmaceuticals. This recall was issued due to the presence of glass particulate matter observed in a retention sample. The administration of glass particulate, if present in an intravenous (IV) drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected.

This recall affects lot number 4750915 exp. 09/17.

This recall was originally issued to the retail/medical facility or physician user level on March 10, 2016. The FDA classified this recall as a Class I Recall on June 1, 2016.

CVS Caremark Response: CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are using amikacin sulfate injection 1 gram/4 mL (250 mg/mL) to contact their prescriber.

For more information about this recall, health care providers may contact Teva Medical Information at 1‑888‑838‑2872 and select option 3 then option 4. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit their Web site at www.fda.gov.