Drug product
Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient, Rx only, Johnson Matthey Pharmaceutical Materials, 2003 Nolte Drive, West Deptford, NJ 08066-1742
D-1077-2019
Product summary
- Event
- Event 82298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 169.976 kg
- Official record key
drug-enforcement:D-1077-2019
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Code information: Lot# B1414-160809, Retest Date AUG 2021
Distribution pattern: Nationwide in the US
Derived failure modes
-
Microbial contamination
Microbial Contamination
-
Potency or specification failure
out of specification