Recalls / Class II
Class IID-0300-2015
Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
- Affected lot / code info
- Lot #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015
Why it was 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.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 3496 cartons
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2014-11-19
- FDA classified
- 2014-12-16
- Posted by FDA
- 2014-12-24
- Terminated
- 2015-06-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0300-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.