Lisinopril Tablets USP recalled over manufacturing violations

Recall date

April 6, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Lupin Pharmaceuticals Inc. recalls Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-…

Recall number

D-1502-2016

FDA classification

Class III

Brand / firm

Lupin Pharmaceuticals Inc.

Sold / distributed

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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Lisinopril Tablets USP, 30 mg, packaged in a) 500-count bottles (NDC 68180-516-02) and b) 100-count bottles (NDC 68180-516-01); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA.