FDAClass IIIMay 14, 2014

Mercaptopurine Tablets USP recall: Labeling Error

Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11

Why was Mercaptopurine Tablets USP recalled?

Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16

Product
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
Recalling firm
Boehringer Ingelheim Roxane Inc
Quantity
98,560 bottles
Distribution
Nationwide
Recall date
May 14, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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