FDA Drug recall D-1247-2015
Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only
- FDA Drug
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only by Wockhardt Usa, citing CGMP Deviations: Firm did not adequately investigate customer complaints.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1247-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-22 |
| Published | 2015-07-29 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Wockhardt Usa |
| Distribution | US |
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.
Reason
CGMP Deviations: Firm did not adequately investigate customer complaints.
Identifiers
| code_info | Lot #: DM11802, Expiry: 6/30/2015; Lot #: DM11803, Expiry: 6/30/2015; Lot #: DM12273, Expiry: 7/31/2015; Lot #: DM12274, Expiry: 7/31/2015. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1247-2015%22
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