Reported May 21, 2014 · Terminated
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05),…
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?
INDOMETHACIN Capsules USP50 mga) 100 count bottle(NDC 0093-4030-01)b) 500 count bottle(NDC 0093-4030-05)
- Manufactured In INDIA ByEMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India
- Manufactured ForTEVA PHARMACEUTICALS USA, Sellersville, PA 18960
- Lot codes and dates
TE38139Exp. 08/16TE39022Exp. 09/16
- Amount recalled
- 5812 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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