Recalls / Class II
Class IID-1668-2012
Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.
- Affected lot / code info
- Lot #: 120604 Exp 2/28/2013
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 Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 694 cartons
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2012-07-23
- FDA classified
- 2012-08-29
- Posted by FDA
- 2012-09-05
- Terminated
- 2013-02-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1668-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.