Recalls / Class II
Class IID-1294-2014
Product
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01
- Affected lot / code info
- TE32134, Exp. 02/15
Why it was recalled
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 7,694 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-03-24
- FDA classified
- 2014-05-12
- Posted by FDA
- 2014-05-21
- Terminated
- 2014-11-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1294-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.