Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD

Recalled September 28, 2016 · FDA recall D-1503-2016 · Lupin Pharmaceuticals

Hazard

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications. · FDA Class III

Units

5,880 bottles

Sold at

All product distributed domestically in the US. No recalled product was distributed to U.S. Government Agency consignees directly by Lupin. No recalled product was distributed to any foreign consignees by Lupin.

Description

CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Product

Lisinopril Tablets USP, 40 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-517-03.

Manufacturer(s)

Lupin Pharmaceuticals Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →