Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements
American Health Packaging is recalling 694 cartons of Mercaptopurine Tablets, USP, 50 mg, because the lot failed USP dissolution test requirements.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of the product could cause temporary or medically reversible health consequences. The failure of dissolution tests is a quality control issue that may affect drug efficacy, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
American Health Packaging is recalling 694 cartons of Mercaptopurine Tablets, USP, 50 mg. The affected product is packaged in 30-tablet unit dose blisters (3 x 10) per carton and is labeled for distribution by Par Pharmaceutical Companies, Inc. The specific lot number is 120604, with an expiration date of 2/28/2013.
The recall is being conducted because the product failed USP dissolution test requirements. This action is a sub-recall in response to a recall initiated by Prometheus Laboratories Inc. for Mercaptopurine USP 50mg due to the same specification failure.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for guidance on replacement or return.
The recalled product
- 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
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 694
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: 120604 Exp 2/28/2013
Distribution
Distributed nationwide across the United States.
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