Recalls / Class II

Class IID-1257-2015

Product

Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Affected lot / code info

A) Lot #: DM10991, Expiry: 4/30/2015; Lot #: DM11226, Expiry: 4/30/2015; Lot #: DM11665, Expiry: 6/30/2015; Lot #: DM11810, Expiry: 6/30/2015; Lot #: DM12702, Expiry: 9/30/2015; Lot #: DN10719, Expiry: 1/31/2016. B) Lot #: DM11651, Expiry: 6/30/2015; Lot #: DM11652, Expiry: 6/30/2015; Lot #: DM11664, Expiry: 6/30/2015; Lot #: DM12701, Expiry: 9/30/2015; Lot #: DN10139, Expiry: 12/31/2015. C) Lot #: DM11041, Expiry: 4/30/2015; Lot #: DM11267, Expiry: 4/30/2015; Lot #: DM11268, Expiry: 4/30/2015; Lot #: DM11279, Expiry: 5/31/2015; Lot #: DM11286, Expiry: 5/31/2015; Lot #: DM11292, Expiry: 5/31/2015; Lot #: DM11625, Expiry: 6/30/2015; Lot #: DM11626, Expiry: 6/30/2015; Lot #: DM11670, Expiry: 6/30/2015; Lot #: DM11772, Expiry: 6/30/2015; Lot #: DM11773, Expiry: 6/30/2015; Lot #: DM11809, Expiry: 6/30/2015; Lot #: DM12698, Expiry: 9/30/2015; Lot #: DN10110, Expiry: 11/30/2015; Lot #: DN10608, Expiry: 1/31/2016; Lot #: DN10642, Expiry: 1/31/2016; Lot #: DN10694, Expiry: 1/31/2016; Lot #: DN10744, Expiry: 1/31/2016; Lot #: DN10799, Expiry: 1/31/2016; Lot #: DN10839; Expiry: 2/29/2016.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Recalling firm

Firm

Wockhardt Usa Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271

Distribution

Quantity

A) 128,594 Bottles, B) 25,472 Bottles, and C) 62,124 Bottles.

Distribution pattern

U.S. Nationwide including Puerto Rico.

Timeline

Recall initiated

2015-04-22

FDA classified

2015-07-17

Posted by FDA

2015-07-29

Terminated

2018-05-09

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1257-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.