FDA Drug Class II — Moderate

Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), 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

Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai,
Brand
Wockhardt Usa Inc.
UPC
A) Lot #: DM11608, Expiry: 5/31/2015; Lot #: DM11609, Expiry: 5/31/2015; Lot #: DN10190, Expiry: 12/31/2015. B) Lot #: DM11186, Expiry: 4/30/2015; Lot #: DM11607, Expiry: 5/31/2015; Lot #: DM13298, Expiry: 10/31/2015; Lot #: DN10188, Expiry: 12/31/2015; Lot #: DN10189, Expiry: 12/31/2015.

Units Affected

A) 36,213 Bottles and B) 12,824 Bottles.