Drug product
methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10
D-0012-2018
Product summary
- Event
- Event 78175
- Status
- Terminated
- Classification
- Class II
- Quantity
- 945 vials
- Official record key
drug-enforcement:D-0012-2018
Official wording
Reason: Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Code information: Lot: 04252017@1, exp 5/9/2018
Distribution pattern: TX, LA, PA, MA, FL, and OH
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility