Drug product
Midazolam 1 mg/mL (Midazolam HCL (USP) 100 mg, Sodium Chloride, USP QS 100 mL) Volume: 100 mL. Single dose bag. Avella of Houston, 9265 Kirby Dr., Houston TX 77054. NDC 4252-401-10
D-0937-2018
Product summary
- Event
- Event 80307
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1860 bags
- Official record key
drug-enforcement:D-0937-2018
Official wording
Reason: Lack of Assurance of Sterility: Potential leakage of bags.
Code information: Lot # 5/7/18 7482 40110P, BUD 9/4/2018; 5/22/18 0804 40110P, BUD 9/19/2018; 5/3/18 1111 40110P, BUD 8/31/2018.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility