FDA Drug recall D-1262-2015
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-71…
- FDA Drug
- Class II
- terminated
- Published 2015-07-29
On 2015-07-29 the FDA classified a Class II recall of Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-71… 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-1262-2015 |
| 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, 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
CGMP Deviations: Firm did not adequately investigate customer complaints.
Identifiers
| code_info | A) Lot #: DM11608, Expiry: 5/31/2015; Lot #: DM11609, Expiry: 5/31/2015; Lot #: DN10190, Expiry: 12/31/2015. B) Lot #:…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Wockhardt Usa
- Enalapril Maleate tablets, USP, 5mg, 1000-count bottles, Rx only, Manufactured by: Wockhardt Limited H-14/2, M.I.D.C. Area, Waluj, Aurangab…
FDA Drug · Class III · 2017-11-01 · Wockhardt Usa - Lisinopril Tablets USP, 5 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa - Lisinopril Tablets USP, 20 mg, 1000-count bottles, Rx Only, Manufactured by: Wockhardt Limited, Mumbai, India
FDA Drug · Class II · 2015-08-26 · Wockhardt Usa - Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 6467…
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa - Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only
FDA Drug · Class II · 2015-07-29 · Wockhardt Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1262-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.