Reported Jul 29, 2015 · Terminated
Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count…
Wockhardt USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271
Is this the product you have?
- Zolpidem Tartrate Tablets, 10 mg Tablets, CIV
- Packaged in A) 100 Count Bottles (NDC64679-715-01)
- and B) 500 Count Bottles (NDC64679-715-04), Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 DM11608, Expiry: 5/31/2015 2 Lot #: DM11609, Expiry: 5/31/2015 3 Lot #: DN10190, Expiry: 12/31/2015. B) Lot #: DM11186, Expiry: 4/30/2015 4 Lot #: DM11607, Expiry: 5/31/2015 5 Lot #: DM13298, Expiry: 10/31/2015 6 Lot #: DN10188, Expiry: 12/31/2015 7 Lot #: DN10189, Expiry: 12/31/2015. - Amount recalled
- A) 36,213 Bottles and B) 12,824 Bottles.
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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