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
Reported: May 21, 2014 Initiated: March 24, 2014 #D-1294-2014
Product Description
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
Reason for Recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 7,694 bottles
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 7,694 bottles.
Why was this product recalled? ▼
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 21, 2014. Severity: Moderate. Recall number: D-1294-2014.
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