FDA Drug Class II — Moderate

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

Products

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany,
Brand
Wockhardt Usa Inc.
UPC
Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.

Units Affected

124,034 Bottles