FDA-Drug2016-09-28Class III

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.

Lupin Pharmaceuticals Inc.
Hazard

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

Sold states
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.
Affected count
5,880 bottles
Manufactured in
111 S Calvert St Fl 21ST, Baltimore, MD, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1503-2016

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