Recall: D-1503-2016

Class III - Minor Violations

Class IIIClassification
2016-04-06Initiated
TerminatedStatus
Lupin Pharmaceuticals Inc.Firm

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.

Reason

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

Distribution

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.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.