FDA recall D-1346-2015

Product

Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC, 20 Waterview Blvd, Parsippany, NJ 07054 USA, UPC 3 64679 92806 6, NDC 64679-928-06.

Reason for recall

CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-07-29

Report date

2015-08-26

Termination date

2017-04-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1346-2015