Depression Med Pulled

InvaGen Pharmaceuticals Inc. issued a recall for 26,496 bottles of 90-count bupropion hydrochloride extended-release tablets USP, 150 mg, after tested samples failed to meet impurity specifications. The recall was included in the September 26, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 90-count bottles manufactured for Cipla USA Inc. (NDC 69097-875-05) from lots 1612130 and 1612131 (Exp. 11/18), 1709986 (Exp 8/19), and 1711549 (Exp. 10/19).

The recall also includes 90-count bottles manufactured for BluePoint Laboratories (NDC 68001-322-05) from lots 1701171, 1701174, 1701175, and 1701176 (Exp. 12/18), 1705131, 1705132, and 1705133 (Exp 4/19), 1709986 and 1709985 (Exp. 8/19), 17110257 (Exp. 9/19), 1712809, 1801041, and 1801051 (Exp. 12/19), and 1802283 (Exp. 1/20).

According to the FDA, the affected bupropion was sent to 14 major distributors who then shipped the product throughout the United States.

InvaGen Pharmaceuticals, a subsidiary of Cipla Ltd., voluntarily initiated the recall September 6, 2018. The FDA designated the recall Class III September 25, 2018. The classification suggests use of the recalled drugs is not likely to cause adverse health consequences.

Bupropion is a prescription antidepressant and smoking cessation aid.

—Jolynn Tumolo

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