Drug product
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01.
D-1247-2015
Product summary
- Event
- Event 71104
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,791 Bottles
- Official record key
drug-enforcement:D-1247-2015
Official wording
Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.
Code information: Lot #: DM11802, Expiry: 6/30/2015; Lot #: DM11803, Expiry: 6/30/2015; Lot #: DM12273, Expiry: 7/31/2015; Lot #: DM12274, Expiry: 7/31/2015.
Distribution pattern: U.S. Nationwide including Puerto Rico.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations