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
Reported: May 21, 2014 Initiated: March 24, 2014 #D-1295-2014
Product Description
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
Reason for Recall
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Details
- Recalling Firm
- Teva Pharmaceuticals USA
- Units Affected
- 5812 bottles
- Distribution
- Nationwide
- Location
- Horsham, PA
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Teva Pharmaceuticals USA. Units affected: 5812 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-1295-2014.
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