drugs Class II Updated 2014-11-26

Prometheus Laboratories Inc. recalls Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49

Recalled Product

Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121

Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related drugs Recalls

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Ben Venue Laboratories Inc recalls Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, pac

2012-06-20 · Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.