Recalls / Class II

Class IID-1244-2015

Product

Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), 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 #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry: 1/1/2016. B) Lot #: DM11122, Expiry: 4/30/2015; Lot #: DM11130, Expiry: 4/30/2015; Lot #: DM11533, Expiry: 5/31/2015; Lot #: DM11674, Expiry: 6/30/2015; Lot #: DM11675, Expiry: 6/30/2015; Lot #: DM12497, Expiry: 8/31/2015; Lot #: DM13336, Expiry: 11/30/2015; Lot #: DN10289, Expiry: 12/31/2015; Lot #: DN10445, Expiry: 1/31/2016; Lot #: DN10816, Expiry: 1/31/2016; Lot #: DN10817, Expiry: 1/31/2016; Lot #: DN10976, 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) 149,924 Bottles and B) 35,012 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-1244-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.