Reported Jul 29, 2015 · Terminated
Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC:…
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, 40 mg Tablets
- Packaged in A) 30 Count Bottles (NDC64679-937-01)
- B) 100 Count Bottles (NDC64679-937-02)
- and C) 1000 Count Bottles (NDC64679-937-03), Rx only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
25 of 25 products
Products covered by this recall # Product as published 1 LM10806, Expiry: 5/31/2015 2 Lot #: LM11099, Expiry: 6/30/2015 3 Lot #: LM11297, Expiry: 7/31/2015 4 Lot #: LM11933, Expiry: 10/31/2015 5 Lot #: LN10180, Expiry: 12/31/2015 6 Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015 7 Lot #: LM10791, Expiry: 5/31/2015 8 Lot #: LM10812, Expiry: 5/31/2015 9 Lot #: LM11112, Expiry: 6/30/2015 10 Lot #: LM11298, Expiry: 7/31/2015 11 Lot #: LM11299, Expiry: 7/31/2015 12 Lot #: LM11625, Expiry: 8/31/2015 13 Lot #: LN10182, Expiry: 12/31/2015 14 Lot #: LN10548, Expiry: 2/29/2016 15 Lot #: LN11115, Expiry: 5/31/2016 16 Lot #: LN11367, Expiry: 8/31/2016 17 Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015 18 Lot #: LM11085, Expiry: 6/30/2015 19 Lot #: LM11088, Expiry: 6/30/2015 20 Lot #: LM11296, Expiry: 7/31/2015 - Amount recalled
- A) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 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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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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