Drug product
Midazolam 1 mg/mL (Midazolam HCL USP 30 mg, 0.9% Sodium Chloride, USP QS 30 mL) Volume: 30 mL. Single dose syringe. For: Methodist Willowbrook Hospital, By: Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-63
D-0955-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0955-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot #:5/11/18 1050 28-40163M, BUD 7/25/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility