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, 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 NDC
0093-4029-01
Compare with the code on your package — it is the most precise check available.
Drug: Indomethacin
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0093-4029-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1294-2014 · 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
CGMP Deviations
Class II · Moderate risk
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Class II · Moderate risk
traZODone Hydrochloride Tablets
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Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
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Class II · Moderate risk
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