Mercaptopurine Tablets Recalled for Failed Dissolution Test Requirements
American Health Packaging is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defect is a failure to meet dissolution specifications, which is a quality control issue rather than a direct contamination or mislabeling of a high-risk allergen.
Plain-English summary
American Health Packaging is recalling 3,496 cartons of Mercaptopurine Tablets, USP, 50 mg. The product is distributed in 30-tablet unit dose blisters (3 x 10) per carton and is marked for prescription use only. The tablets were manufactured by Prometheus Laboratories Inc. and repackaged by American Health Packaging.
The recall was initiated because the affected lots failed to meet the specification for dissolution, as required by USP standards. This sub-recall is in response to a broader recall by Prometheus Laboratories Inc. for the same product.
The affected lots are 142450 (Exp 05/2015), 140862 (Exp 02/2015), 141596 (Exp 03/2015), and 134770 (Exp 01/2015). The product was distributed nationwide. Patients and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If found, the product should be returned to the pharmacy or healthcare provider for replacement or refund.
The recalled product
- 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…
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,496
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 (4)
- Lot #: 142450 Exp 05/2015
- 140862 Exp 02/2015
- 141596 Exp 03/2015
- 134770 Exp 01/2015
Distribution
Distributed nationwide across the United States.
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