FDA Drug Class II — Moderate

Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), 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, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactu
Brand
Wockhardt Usa Inc.
UPC
A) Lot #: DM11197, Expiry: 4/30/2015; Lot #: DM11202, Expiry: 4/30/2015; Lot #: DM11641, Expiry: 6/30/2015; Lot #: DM12237, Expiry: 8/31/2015; Lot #: DM12238, Expiry: 8/31/2015, Lot #: DM12285, Expiry: 8/31/2015; Lot #: DN10176, Expiry: 12/31/2015; Lot #: DN10636, Expiry: 1/31/2016; Lot #: DN10869, Expiry: 2/29/2016. B) Lot #: DM11646, Expiry: 6/30/2015; Lot #: DM12364, Expiry: 8/31/2015. C) Lot #: DM11136, Expiry: 4/30/2015; Lot #: DM11137, Expiry: 4/30/2015; Lot #: DM11142, Expiry: 4/30/2015; Lot #: DM11150, Expiry: 4/30/2015; Lot #: DM11176, Expiry: 4/30/2015; Lot #: DM11212, Expiry: 4/30/2015; Lot #: DM11213, Expiry: 5/31/2015; Lot #: DM11214, Expiry: 5/31/2015; Lot #: DM11222, Expiry: 5/31/2015; Lot #: DM11223, Expiry: 5/31/2015; Lot #: DM11270, Expiry: 5/31/2015; Lot #: DM11277, Expiry: 5/31/2015; Lot #: DM11278, Expiry: 5/31/2015; Lot #: DM11289, Expiry: 5/31/2015; Lot #: DM11290, Expiry: 5/31/2015; Lot #: DM11291, Expiry: 5/31/2015; Lot #: DM11322, Expiry: 5/31/2015; Lot #: DM11499, Expiry: 5/31/2015; Lot #: DM11538, Expiry: 5/31/2015; Lot #: DM11539, Expiry: 5/31/2015; Lot #: DM11540, Expiry: 5/31/2015, Lot #: DM11541, Expiry: 5/31/2015; Lot #: DM11542, Expiry: 5/31/2015; Lot #: DM11543, Expiry: 5/31/2015; Lot #: DM11601, Expiry: 6/30/2015; Lot #: DM11602, Expiry: 6/30/2015; Lot #: DM11617, Expiry: 6/30/2015; Lot #: DM11623, Expiry: 6/30/2015; Lot #: DM11624, Expiry: 6/30/2015; Lot #: DM11825, Expiry: 6/30/2015; Lot #: DM11826, Expiry: 6/30/2015; Lot #: DM11831, Expiry: 6/30/2015; Lot #: DM11875, Expiry: 6/30/2015; Lot #: DM11876, Expiry: 6/30/2015; Lot #: DM11877, Expiry: 6/30/2015; Lot #: DM11878, Expiry: 6/30/2015: Lot #: DM11883, Expiry: 6/30/2015, Lot #: DM11918, Expiry: 6/30/2015; Lot #: DM11919, Expiry: 6/30/2015; Lot #: DM11922, Expiry: 7/31/2015; Lot #: DM11923, Expiry: 7/31/2015; Lot #: DM11962, Expiry: 7/31/2015; Lot #: DM11963, Expiry: 7/31/2015; Lot #: DM12248, Expiry: 8/31/2015; Lot #: DM12249, Expiry: 8/31/2015; Lot #: DM12263, Expiry: 8/31/2015: Lot #: DM12306, Expiry: 8/31/2015; Lot #: DM12317, Expiry: 8/31/2015; Lot #: DM12349, Expiry: 8/31/2015; Lot #: DM12350, Expiry: 8/31/2015; Lot #: DM12351, Expiry: 8/31/2015; Lot #: DM12388, Expiry: 8/31/2015; Lot #: DM12389, Expiry: 8/31/2015; Lot #: DM13100, Expiry: 9/30/2015; Lot #: DM13052, Expiry: 9/30/2015; Lot #: DM13053, Expiry: 9/31/2015; Lot #: DM13101, Expiry: 9/30/2015; Lot #: DM13354, Expiry: 9/30/2015; Lot #: DN10148, Expiry: 11/30/2015; Lot #: DN10152, Expiry: 11/30/2015; Lot #: DN10154, Expiry: 12/31/2015; Lot #: DN10155, Expiry: 12/31/2015; Lot #: DN10175, Expiry: 12/31/2015; Lot #: DN10180; Expiry: 12/31/2015; Lot #: DN10185, Expiry: 12/31/2015; Lot #: DN10195, Expiry: 12/31/2015; Lot #: DN10204, Expiry: 12/31/2015; Lot #: DN10213, Expiry: 12/31/2015; Lot #: DN10594, Expiry: 1/31/2016; Lot #: DN10595, Expiry: 1/31/2016; Lot #: DN10606, Expiry: 1/31/2016; Lot #: DN10607, Expiry: 1/31/2016; Lot #: DN10630, Expiry: 1/31/2016; Lot #: DN10637, Expiry: 1/31/2016; Lot #: DN10638, Expiry: 1/31/2016; Lot #: DN10767, Expiry: 2/29/2016; Lot #: DN10768, Expiry: 2/29/2016; Lot #: DN10769, Expiry: 9/30/2015; Lot #: DN10777, Expiry: 2/29/2016; Lot #: DN10782, Expiry: 2/29/2016; Lot #: DN10783, Expiry: 1/31/2016; Lot #: DN10784, Expiry: 2/29/2016; Lot #: DN10834, Expiry: 2/29/2016; Lot #: DN10835, Expiry: 2/29/2016.

Units Affected

A) 133,920 Bottles, B) 6705 Bottles, and C) 137,659 Bottles.