Reported Jul 29, 2015 · Terminated
Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited,…
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?
- Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- NDC64679-0990-01
- Lot codes and dates
68 of 68 products
Products covered by this recall # Product as published 1 LM10776, Expiry: 5/31/2015 2 Lot #: LM10781, Expiry: 5/31/2015 3 Lot #: LM10783, Expiry: 5/31/2015 4 Lot #: LM10923, Expiry: 4/30/2015 5 Lot #: LM10924, Expiry: 4/30/2015 6 Lot #: LM10925, Expiry: 4/30/2015 7 Lot #: LM10926, Expiry: 5/31/2015 8 Lot #: LM10927, Expiry: 5/31/2015 9 Lot #: LM10937, Expiry: 6/30/2015 10 Lot #: LM11138, Expiry: 6/30/2015 11 Lot #: LM11139, Expiry: 6/30/2015 12 Lot #: LM11141, Expiry: 6/30/2015 13 Lot #: LM11180, Expiry: 6/30/2015 14 Lot #: LM11181, Expiry: 6/30/2015 15 Lot #: LM11319, Expiry: 7/31/2015 16 Lot #: LM11320, Expiry: 7/31/2015 17 Lot #: LM11356, Expiry: 7/31/2015 18 Lot #: LM11357, Expiry: 7/31/2015 19 Lot #: LM11363, Expiry: 7/31/2015 20 Lot #: LM11407, Expiry: 7/31/2015 - Amount recalled
- 491,360 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.
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