Drug product
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
D-0456-2017
Product summary
- Event
- Event 76001
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47, 020 vials
- Official record key
drug-enforcement:D-0456-2017
Official wording
Reason: Failed Impurities/Degradation Specifications
Code information: Lot 6007327, exp. 01-2017; Lot 6007329, exp. 01-2017
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications