Reported May 21, 2014 · Terminated
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE…
Teva Pharmaceuticals USA
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: Teva Pharmaceuticals USA · 425 Privet Rd · Horsham, PA · 19044-1220
Is this the product you have?
- GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle
- Manufactured In INDIA ByEMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India
- Manufactured ForTEVA PHARMACEUTICALS USA, Sellersville, PA 18960
- NDC0093-5712-05
- Lot codes and dates
TE36018Exp. 06/15
- Amount recalled
- 2532 bottles
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
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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