Reported Jul 29, 2015 · Terminated
Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 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, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- NDC64679-0374-09
- Lot codes and dates
- Lot #: LN11320
- Expiry
7/31/2015Lot #: LN11341
- Expiry8/31/2015
- Amount recalled
- 539 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.
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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