Drug product
All Sterile Products within expiry
D-0148-2018
Product summary
- Event
- Event 77978
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61 Products
- Official record key
drug-enforcement:D-0148-2018
Official wording
Reason: Lack of Assurance of Sterility .
Code information: Lack of Sterility Assurance: A recent FDA inspection revealed poor aseptic production practices that result in lack of sterility assurance of products
Distribution pattern: Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility