Drugplain

Mercaptopurine 50 mg/1

mercaptopurine · TABLET · Mylan Pharmaceuticals Inc.

6 Recalls on Record
Plain English

Mercaptopurine is a tablet containing mercaptopurine at 50 mg/1, taken oral. Manufactured by Mylan Pharmaceuticals Inc..

Key Facts

Brand Name
Mercaptopurine
Generic Name
mercaptopurine
NDC Code (Product)
0378-3547
Manufacturer
Mylan Pharmaceuticals Inc.
Strength
50 mg/1
Dosage Form
TABLET
Route
ORAL
Marketing Status
Application #
ANDA040594
Marketing Start
07/01/2005

Recall History

6 Recalls on Record
Class III04/04/2014

Boehringer Ingelheim Roxane Inc

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.

TerminatedVoluntary: Firm initiated
Class II11/19/2014

American Health Packaging

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

TerminatedVoluntary: Firm initiated
Class III02/09/2024

Stason Pharmaceuticals, Inc.

Failed Dissolution Specifications: results slightly under spec at at 9-months.

TerminatedVoluntary: Firm initiated
Class II06/29/2012

Prometheus Laboratories Inc.

Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.

TerminatedVoluntary: Firm initiated
Class II07/23/2012

American Health Packaging

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

TerminatedVoluntary: Firm initiated
Class II10/22/2014

Prometheus Laboratories Inc.

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

febrile neutropenia1,877 reports
pyrexia1,183 reports
off label use1,119 reports
drug ineffective1,095 reports
nausea783 reports
vomiting742 reports
diarrhoea688 reports
abdominal pain683 reports
headache596 reports
neutropenia592 reports

Frequently Asked Questions

What is Mercaptopurine used for?

Mercaptopurine contains mercaptopurine. It is a tablet taken oral. Consult your doctor for specific uses.

Is Mercaptopurine a controlled substance?

Mercaptopurine is not classified as a controlled substance by the DEA.

What is the generic name for Mercaptopurine?

The generic name for Mercaptopurine is mercaptopurine. There are 3 other brand versions of mercaptopurine.

What is the NDC code for Mercaptopurine 50 mg/1?

The NDC (National Drug Code) for Mercaptopurine 50 mg/1 is 0378-3547, listed by Mylan Pharmaceuticals Inc..

Product NDC

0378-3547

Package NDC

0378-3547-52

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)