Antibiotic Recalled Due to Potential Glass Particulate

After finding glass particulate in a vial, Teva Pharmaceuticals is recalling 1 lot of its amikacin sulfate injection USP, 1 gram/4 mL, vials.

Lot number 4750915, expiring in September 2017, is the product affected by this recall.

“Teva is arranging for impacted product to be returned to Inmar,” the FDA stated in a press release. “Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Customers should notify all retail and medical facility accounts.”

In the event that the product is administered with glass particulate, there is an increased risk of irritation and swelling. In serious cases, the glass may cause blockage and clotting in blood vessels and could cause fatal outcomes. However, Teva has not heard of any adverse effects stemming from this product.

Amikacin sulfate injection USP is used to treat infections due to strains of Gram-negative bacteria. It has also been shown to effectively treat staphylococcal infections.

The product falls under a class of medications known as aminoglycoside antibiotics. It is distributed in pharmacy bulk packages containing 10 1 gram/4 mL (250 mg/mL) vials per shelf pack.

Urgent drug recall letters have been sent to direct customers by Teva. This product was distributed to pharmacies, retailers, and wholesalers across the United States.