Ophthalmic Antibiotic Recalled

Alembic Pharmaceuticals Inc is recalling 82,400 bottles of tobramycin ophthalmic solution for failing to meet impurity/degradation specifications, according to the August 23, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects tobramycin ophthalmic solution, 0.3%, in 5-mL bottles (NDC 62332-518-05) from lots AMR103 (Exp 10/23) and AMR201 (Exp 6/24). The drug was manufactured for Alembic Pharmaceuticals, Bedminster, New Jersey, and distributed throughout the United States.

Alembic Pharmaceuticals voluntarily initiated the recall July 27, 2023. The FDA designated it Class III on August 17, 2023. Per the recall classification, use of the affected medication is not likely to cause harm.

Tobramycin ophthalmic solution, 0.3 %, is a prescription topical antibiotic indicated in the treatment of external infections of the eye caused by susceptible bacteria.