PlainRecalls
FDA Drug Moderate Class II Terminated

Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21

Reported: December 24, 2014 Initiated: November 19, 2014 #D-0300-2015

Product Description

Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21

Reason for Recall

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.

Details

Recalling Firm
American Health Packaging
Units Affected
3496 cartons
Distribution
Nationwide.
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21. Recalled by American Health Packaging. Units affected: 3496 cartons.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 24, 2014. Severity: Moderate. Recall number: D-0300-2015.