FDAClass IIMay 21, 2014

Glyburide and Metformin Hydrochloride Tablets USP recall: CGMP Deviations

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals…

Why was Glyburide and Metformin Hydrochloride Tablets 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?

TE36018, Exp. 06/15

Product
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals…
Recalling firm
Teva Pharmaceuticals USA
Quantity
2532 bottles
Distribution
Nationwide
Recall date
May 21, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls