Why it was recalled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Product description
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
Lot numbers, UPCs & expiration codes
Lot# B1414-160809, Retest Date AUG 2021
Where it was sold
Nationwide in the US
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-1077-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 5, 2018
- FDA report date
- Apr 10, 2019
- Quantity
- 169.976 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Johnson Matthey Inc.
Original FDA data
Every field from FDA enforcement report D-1077-2019, exactly as published.
Show all FDA fields
- City
- West Deptford
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82298
- Address
- 2003 Nolte Dr
- Code information
- Lot# B1414-160809, Retest Date AUG 2021
- Postal code
- 08066-1727
- Report date
- Apr 10, 2019
- Product type
- Drugs
- Recall number
- D-1077-2019
- Classification
- Class II
- Recalling firm
- Johnson Matthey Inc.
- Product quantity
- 169.976 kg
- Termination date
- Jul 23, 2021
- Reason for recall
- Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Mar 5, 2018
- Initial firm notification
- Letter
- Center classification date
- Apr 3, 2019