Reported Jun 3, 2015 · Terminated
Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist. By: Wockhardt USA LLC, Parsippany, NJ 07054, Repackaged…
Blenheim Pharmacal, 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: Blenheim Pharmacal, Inc. · 119 Creamery Road · North Blenheim, NY · 12131
Is this the product you have?
- Clarithromycin Tablets, USP, 500 mg, 20 Tablets, Rx Only, Dist
- ByWockhardt USA LLC, Parsippany, NJ 07054
- Repackaged By
Blenheim Pharmacal Inc. North BlenheimNY 12131NDC 10544-522-20
- MFG64679-904-02
- Lot codes and dates
Lot BP18181301Exp. Date 02/29/2016
- Amount recalled
- 50 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
cGMP Deviations; products being recalled in response to a recall notice from the manufacturer, Wockhardt Limited, following a FDA inspection which noted inadequate investigation of market complaints, resulting in unsuccessful identification of root causes, and the investigation not being expanded to prevent repeat failure
This product could cause temporary or reversible health problems — stop using it.
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