Class II · Moderate risk
Indomethacin Extended-Release Capsules
cGMP deviations
INDOMETHACIN Capsules USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What 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
Affected NDCs
0093-4030-01
0093-4030-05
Compare with the code on your package — it is the most precise check available.
Drug: Indomethacin
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0093-4030-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1295-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Indomethacin recalls
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Class II · Moderate risk
Indomethacin Extended-Release Capsules USP
cGMP deviations
Class II · Moderate risk
Indomethacin Extended-Release Capsules
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
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