Boehringer Ingelheim Roxane Recalls Mercaptopurine Tablets Due to Incorrect Expiration Dates
Boehringer Ingelheim Roxane Inc. is recalling Mercaptopurine Tablets USP because they were labeled with 36-month expiration dates instead of the approved 24 months.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Boehringer Ingelheim Roxane Inc. is recalling Mercaptopurine Tablets USP, 50 mg, 25 count bottles. The recall involves 98,560 bottles distributed nationwide. The affected lots are 261997A (Exp 02/16), 262214V (Exp 05/16), and 359283V (Exp 05/16).
The recall is being conducted because the product was labeled with 36-month expiration dates instead of the 24-month expiration dates filed with the FDA. This is a Class III recall, indicating that the product is not likely to cause adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- MERCAPTOPURINE (MERCAPTOPURINE)
- Brand
- MERCAPTOPURINE
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 98,560
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 (3)
- Lot 261997A Exp 02/16
- 262214V
- 359283V Exp. 05/16
UPCs (2)
- 0300544581271
- 0300544581110
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Boehringer Ingelheim Roxane Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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