FDAFDA · Food and drugs·Recall number D-1295-2014
INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960
Published May 21, 2014 · Recall initiated: March 24, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva Pharmaceuticals USA
- Distributor
- Nationwide
- Lot
- TE38139, Exp. 08/16, TE39022, Exp. 09/16,
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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