Boehringer Ingelheim Roxane Recalls Azathioprine Tablets Due to Incorrect Expiration Dates
Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding expiration dates.
Plain-English summary
Boehringer Ingelheim Roxane Inc is recalling 8,304 bottles of Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only (NDC 0054-4084-25). The affected product is identified by Lot 261983A with an expiration date of 11/15. The recall is being conducted because the product was labeled with 36-month expiration dates instead of the filed 24 months.
The recall is classified as Class III by the U.S. Food and Drug Administration. This classification indicates that use of, or exposure to, the violative product is not likely to cause adverse health consequences. The distribution pattern for this recall is nationwide.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance on alternative treatments or replacements. The recall is limited to the specific lot and expiration date listed above.
The recalled product
- Product
- Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
- Manufacturer
- Boehringer Ingelheim Roxane Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 8,304
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 261983A Exp.11/15
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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