FDAClass IIMay 21, 2014

INDOMETHACIN Capsules USP recall: CGMP Deviations

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune…

Why was INDOMETHACIN Capsules USP recalled?

CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

TE32134, Exp. 02/15

Product
INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune…
Recalling firm
Teva Pharmaceuticals USA
Quantity
7,694 bottles
Distribution
Nationwide
Recall date
May 21, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls