Reported Jul 29, 2015 · Terminated
Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter.…
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?
- Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- NDC64679-0972-00
- Lot codes and dates
29 of 29 products
Products covered by this recall # Product as published 1 LM10826, Expiry: 5/31/2015 2 Lot #: LM10999, Expiry: 5/31/2015 3 Lot #: LM11016, Expiry: 6/30/2015 4 Lot #: LM11032, Expiry: 6/30/2015 5 Lot #: LM11038, Expiry: 6/30/2015 6 Lot #: LM11087, Expiry: 6/30/2015 7 Lot #: LM11149, Expiry: 4/30/2015 8 Lot #: LM11156, Expiry: 4/30/2015 9 Lot #: LM11615, Expiry: 8/31/2015 10 Lot #: LN10195, Expiry: 12/31/2015 11 Lot #: LN10323, Expiry: 12/31/2015 12 Lot #: LN10500, Expiry: 1/31/2016 13 Lot #: LN10507, Expiry: 1/31/2016 14 Lot #: LN10514, Expiry: 2/29/2016 15 Lot #: LN10555, Expiry: 2/29/2016 16 Lot #: LN10556, Expiry: 2/29/2016 17 Lot #: LN10565, Expiry: 2/29/2016 18 Lot #: LN10784, Expiry: 3/31/2016 19 Lot #: LN10788, Expiry: 3/31/2016 20 Lot #: LN10831, Expiry: 3/31/2016 - Amount recalled
- 1,002 Drums
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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