PlainRecalls
FDA Drug Moderate Class II Terminated

Lisinopril Tablets USP, 20 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 94106 5, NDC 64679-941-06.

Reported: August 26, 2015 Initiated: July 29, 2015 #D-1347-2015

Product Description

Lisinopril Tablets USP, 20 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 94106 5, NDC 64679-941-06.

Reason for Recall

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

Details

Recalling Firm
Wockhardt Usa Inc.
Units Affected
3378 bottles
Distribution
Nationwide
Location
Parsippany, NJ

Frequently Asked Questions

What product was recalled?
Lisinopril Tablets USP, 20 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 94106 5, NDC 64679-941-06.. Recalled by Wockhardt Usa Inc.. Units affected: 3378 bottles.
Why was this product recalled?
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 26, 2015. Severity: Moderate. Recall number: D-1347-2015.