Opioid Tablets Recalled

Lupin Pharmaceuticals Inc is voluntarily recalling 23,965 bottles of oxycodone hydrochloride tablets after samples yielded an out-of-specification impurity result at 18-month stability testing, according to the January 12, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles of oxycodone hydrochloride tablets, 5 mg (NDC 43386-432-01), from lot S000268 (Exp. 1/22). The tablets were manufactured by Novel Laboratories Inc., Somerset, NJ, for Lupin Pharmaceuticals Inc, Baltimore, MD, and were distributed in New York and Ohio.

Lupin Pharmaceuticals initiated the recall December 29, 2021. The FDA designated the recall Class III on January 5, 2022. Under the recall classification, use of the affected tablets is not likely to cause harm.

Oxycodone hydrochloride is a schedule II narcotic indicated for the management of pain severe enough to require an opioid analgesic when alternative treatments are inadequate.