February 14, 2020
Ascend Laboratories is pulling 4728 bottles of minocycline hydrochloride extended-release tablets because samples failed to meet dissolution specifications during routine testing, according to the February 12, 2020, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count bottles of minocycline hydrochloride extended-release tablets, 105 mg (NDC 67877-438-30), from lot 19140414 (Exp. 12/20). The tablets were manufactured by Alkem Laboratories and distributed by Ascend Laboratories throughout the United States.
Ascend Laboratories voluntarily initiated the recall January 22, 2020. The FDA designated the recall Class III on February 5, 2020. Under the recall classification, use of the affected tablets is not expected to cause harm.
Minocycline is a prescription antibiotic used to treat various bacterial infections.