Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Tests
Prometheus Laboratories is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they 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, and the source text explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity score involving low-risk contamination or quality issues without reported harm.
Plain-English summary
Prometheus Laboratories Inc. is recalling specific lots of Mercaptopurine Tablets, USP, 50 mg. The recall involves two package sizes: 60-count bottles (NDC 49884-922-02) and 250-count bottles (NDC 49884-922-04). The product is distributed by Par Pharmaceutical Companies, Inc. The affected lots are 11A003, 11A004, 11A005, 11L071, 11L072, 11B009, and 11L073.
The reason for the recall is that the recalled lots do not meet the specification for dissolution according to USP test requirements. The source text does not report any illnesses or injuries associated with this recall.
The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product.
The recalled product
- Product
- Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
- Manufacturer
- Prometheus Laboratories Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 (9)
- Lot #s: a) 11A003
- 11A004
- 11A005
- Exp 01/13
- 11L071
- 11L072
- Exp 10/13
- b) 11B009
- 11L073
Distribution
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