FDA Drug Class II — Moderate

Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01.

Hazard

CGMP Deviations: Firm did not adequately investigate customer complaints.

Products

Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 0
Brand
Wockhardt Usa Inc.
UPC
Lot #: LM11354, Expiry: 7/31/2015; Lot #: LM11355, Expiry: 7/31/2015; Lot #: LM11374, Expiry: 7/31/2015; Lot #: LM11626, Expiry: 8/31/2015; Lot #: LM12004, Expiry: 11/30/2015; Lot #: LM12005, Expiry: 11/30/2015; Lot #: LN10080, Expiry: 10/31/2015; Lot #: LN10393, Expiry: 1/31/2016; Lot #: LN10447, Expiry: 1/31/2016; Lot #: LN10736, Expiry: 2/29/2016; Lot #: LN11316, Expiry: 7/31/2016.

Units Affected

68,969 Bottles