Antibiotic Recalled

Several lots of rifampin capsules are being recalled because samples of the drug failed to meet impurity/degradation specifications during testing, according to the January 18, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The product was manufactured by Lupin Pharmaceuticals Inc, Baltimore, Maryland (original NDC 68180-0659-07). The capsules were then repackaged into blister cards by RemedyRepack Inc, Indiana, Pennsylvania (repackaged NDC 70518-2404-00), and distributed to a customer in Pennsylvania. The recall affects the following lots:

• rifampin capsules, 300 mg, packaged in 30-count blister cards from lots J0599794-022322 (Exp. 2/28/23) and J0621369-052622 (Exp. 6/30/23); and
• rifampin capsules, 300 mg, packaged in 30-count bottles from lot A200171 (Exp. 12/23).

Lupin Pharmaceuticals Inc voluntarily recalled the bottles December 12, 2022, and the FDA designated the recall Class II on January 9, 2023. Likewise, RemedyRepack Inc voluntarily recalled the blister cards on December 20, 2022, and the FDA designated the recall Class II on January 6, 2023. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Rifampin is a prescription antibiotic used to treat tuberculosis and the meningococcal carrier state.