FDA recall D-1502-2016

Product

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.

Reason for recall

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.

Key facts

Status

Terminated

Initiation date

2016-04-06

Report date

2016-09-28

Termination date

2017-08-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Baltimore, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1502-2016