INDOMETHACIN Capsules USP recall: CGMP Deviations
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…
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?
TE38139, Exp. 08/16, TE39022, Exp. 09/16,
- Product
- 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…
- Recalling firm
- Teva Pharmaceuticals USA
- Quantity
- 5812 bottles
- Distribution
- Nationwide
- Recall date
- May 21, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)