FDA Drug Class II — Moderate

Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

Products

Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufact
Brand
Wockhardt Usa Inc.
UPC
A) Lot #: DM11334, Expiry: 4/30/2015; Lot #: DM11551, Expiry: 6/30/2015; Lot #: DM11995, Expiry: 7/31/2015; Lot #: DM12007, Expiry: 7/31/2015; Lot #: DM12480, Expiry: 8/31/2015; Lot #: DN10255, Expiry: 12/31/2015; Lot #: DN10410, Expiry: 1/31/2016; Lot #: DN10897, Expiry: 2/29/2016. B) Lot #: DM11556, Expiry: 6/30/2015; Lot #: DM11567, Expiry: 6/30/2015; Lot #: DM12008, Expiry: 7/31/2015; Lot #: DM12482, Expiry: 8/31/2015. C) Lot #: DM11119, Expiry: 4/30/2015; Lot #: DM11131, Expiry: 4/30/2015; Lot #: DM11132, Expiry: 4/30/2015; Lot #: DM11144, Expiry: 4/30/2015; Lot #: DM11145, Expiry: 4/30/2015; Lot #: DM11161, Expiry: 4/30/2015; Lot #: DM11162, Expiry: 4/30/2015; Lot #: DM11181, Expiry: 4/30/2015; Lot #: DM11182, Expiry: 4/30/2015; Lot #: DM11185, Expiry: 4/30/2015; Lot #: DM11335, Expiry: 5/31/2015; Lot #: DM11352, Expiry: 5/31/2015; Lot #: DM11357, Expiry: 5/31/2015; Lot #: DM11358, Expiry: 5/31/2015: Lot #: DM11366, Expiry: 5/31/2015; Lot #: DM11367, Expiry: 5/31/2015: Lot #: DM11390, Expiry: 5/31/2015; Lot #: DM11396, Expiry: 5/31/2015; Lot #: DM11397, Expiry: 5/31/2015; Lot #: DM11407, Expiry: 5/31/2015; Lot #: DM11408, Expiry: 5/31/2015; Lot #: DM11410, Expiry: 5/31/2015; Lot #: DM11427, Expiry: 5/31/2015; Lot #: DM11428, Expiry: 5/31/2015; Lot #: DM11443, Expiry: 5/31/2015; Lot #: DM11983, Expiry: 7/31/2015; Lot #: DM11984, Expiry: 7/31/2015; Lot #: DM11985, Expiry: 7/31/2015; Lot #: DM11986, Expiry: 7/31/2015; Lot #: DM11996, Expiry: 7/31/2015; Lot #: DM12005, Expiry: 7/31/2015; Lot #: DM12006, Expiry: 7/31/2015; Lot #: DM12045, Expiry: 7/31/2015; Lot #: DM12046, Expiry: 7/31/2015; Lot #: DM12056, Expiry: 7/31/2015; Lot #: DM12057, Expiry: 7/31/2015; Lot #: DM12061, Expiry: 7/31/2015; Lot #: DM12065, Expiry: 7/31/2015; Lot #: DM12079, Expiry: 7/31/2015; Lot #: DM12080, Expiry: 7/31/2015; Lot #: DM12453, Expiry: 8/31/2015; Lot #: DM12455, Expiry: 8/31/2015; Lot #: DM12466, Expiry: 8/31/2015; Lot #: DM12467, Expiry: 8/31/2015; Lot #: DM12478, Expiry: 8/31/2015; Lot #: DM12479, Expiry: 8/31/2015; Lot #: DM13072, Expiry: 10/31/2015; Lot #: DM13093, Expiry: 10/31/2015; Lot #: DM13098, Expiry: 10/31/2015; Lot #: DM13099, Expiry: 10/31/2015; Lot #: DM13220, Expiry: 10/31/2015; Lot #: DM13221, Expiry: 10/31/2015; Lot #: DM13362, Expiry: 11/30/2015; Lot #: DM13363, Expiry: 11/30/2015; Lot #: DM13386, Expiry: 11/30/2015; Lot #: DM13392, Expiry: 11/30/2015; Lot #: DM13414, Expiry: 11/30/2015: Lot #: DM13441, Expiry: 11/30/2015; Lot #: DM13454, Expiry: 11/30/2015; Lot #: DN10253, Expiry: 12/31/2015; Lot #: DN10254, Expiry: 12/31/2015; Lot #: DN10261, Expiry: 12/31/2015; Lot #: DN10262, Expiry: 12/31/2015; Lot #: DN10282, Expiry: 12/31/2015; Lot #: DN10283, Expiry: 12/31/2015; Lot #: DN10284, Expiry: 12/31/2015; Lot #: DN10293, Expiry: 12/31/2015; Lot #: DN10294, Expiry: 12/31/2015; Lot #: DN10295, Expiry: 12/31/2015; Lot #: DN10309, Expiry: 12/31/2015; Lot #: DN10411, Expiry: 1/31/2016; Lot #: DN10455, Expiry: 1/31/2016; Lot #: DN10464, Expiry: 1/31/2016; Lot #: DN10485, Expiry: 1/31/2016; Lot #: DN10497, Expiry: 1/31/2016; Lot #: DN10505, Expiry: 1/31/2016; Lot #: DN10506, Expiry: 1/31/2016; Lot #: DN10524, Expiry: 1/31/2016; Lot #: DN10534, Expiry: 1/31/2016; Lot #: DN10535, Expiry: 1/31/2016; Lot #: DN10554, Expiry: 1/31/2016; Lot #: DN10555, Expiry: 1/31/2016; Lot #: DN10909, Expiry: 2/29/2016; Lot #: DN10910, Expiry: 2/29/2016; Lot #: DN10923, Expiry: 2/29/2016; Lot #: DN10928, Expiry: 3/31/2016; Lot #: DN10929, Expiry: 3/31/2016; Lot #: DN10954, Expiry: 3/31/2016; Lot #: DN10970, Expiry: 3/31/2016; Lot #: DN10971, Expiry: 3/31/2016; Lot #: DN10986, Expiry: 3/31/2016; Lot #: DN10987, Expiry: 3/31/2016.

Units Affected

A) 121,608 Bottles, B) 11,000 Bottles, and C) 152,773 Bottles.