US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 24, 2014 (12 years ago)

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By…

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

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

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

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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