Drug product
Midazolam Benzodiazepine 50 mg/50 mL (1 mg/mL) Injectable Solution, Midazolam HCl 0.9% Sodium Chloride, QS, Sterile single use bag, NDC: 42852-401-05 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404
D-1019-2019
Product summary
- Event
- Event 82398
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1125 bags
- Official record key
drug-enforcement:D-1019-2019
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lots: 12/03/18 9479 40105P Exp. 4/2/2019; 12/3/18 6583 40105P Exp. 4/2/2019; 12/3/18 8918 40105P Exp. 4/2/2019; 12/03/18 4727 40105P Exp. 4/2/2019
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility