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Class III: unlikely to cause harmTerminated

Boehringer Ingelheim Roxane Mercaptopurine Tablets Recall

Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc

Boehringer Ingelheim Roxane Inc · Columbus, OH

Risk level
Class III
Reported by FDA
May 14, 2014
Recall ID
D-1314-2014
Check your lot numberHow we source this data

Summary

Boehringer Ingelheim Roxane recalled Mercaptopurine Tablets starting Apr 4, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1314-2014 on May 14, 2014. Reason: 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. Status: Terminated.

Why it was 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.

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1314-2014
Classification
Class III
Status
Terminated
Recall initiated
Apr 4, 2014
FDA report date
May 14, 2014
Quantity
98,560 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Boehringer Ingelheim Roxane Inc

Original FDA data

Every field from FDA enforcement report D-1314-2014, exactly as published.

Show all FDA fields
City
Columbus
State
OH
Status
Terminated
Country
United States
Event ID
67928
Address
1809 Wilson Rd
Code information
Lot 261997A Exp 02/16; 262214V, 359283V Exp. 05/16
Postal code
43228-9579
Report date
May 14, 2014
Product type
Drugs
Recall number
D-1314-2014
Classification
Class III
Recalling firm
Boehringer Ingelheim Roxane Inc
Product quantity
98,560 bottles
Termination date
Apr 1, 2015
Reason for recall
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.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
Distribution pattern
Nationwide
Recall initiation date
Apr 4, 2014
Initial firm notification
Letter
Center classification date
May 6, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1314-2014, published May 14, 2014. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

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