FDAClass IIDecember 24, 2014

Mercaptopurine Tablets recall: Failed Dissolution

Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410…

Why was Mercaptopurine Tablets recalled?

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

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?

Lot #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015

Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410…
Recalling firm
American Health Packaging
Quantity
3496 cartons
Distribution
Nationwide.
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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