D-1262-2015 Class II Terminated
FDA drug recall D-1262-2015 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: A) 36,213 Bottles and B) 12,824 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
- A) 36,213 Bottles and B) 12,824 Bottles.
Product description
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.
Reason for recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Distribution pattern
U.S. Nationwide including Puerto Rico.
Code information
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1262-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026