Why it was recalled
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Product description
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 numbers, UPCs & expiration codes
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.
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-0249-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 22, 2014
- FDA report date
- Nov 26, 2014
- Quantity
- 16,296 bottles (60-count), 5,166 bottles (250-count)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prometheus Laboratories Inc.
Original FDA data
Every field from FDA enforcement report D-0249-2015, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 69572
- Address
- 9410 Carroll Park Dr
- Code information
- 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.
- Postal code
- 92121-5201
- Report date
- Nov 26, 2014
- Product type
- Drugs
- Recall number
- D-0249-2015
- Classification
- Class II
- Recalling firm
- Prometheus Laboratories Inc.
- Product quantity
- 16,296 bottles (60-count), 5,166 bottles (250-count)
- Termination date
- Feb 18, 2016
- Reason for recall
- Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 22, 2014
- Initial firm notification
- Letter
- Center classification date
- Nov 14, 2014