D-1247-2015 Class II Terminated
FDA drug recall D-1247-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: 37,791 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 29, 2015
- Initiation Date
- Apr 22, 2015
- Termination Date
- May 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 37,791 Bottles
Product description
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.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Distribution pattern
U.S. Nationwide including Puerto Rico.
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1247-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026