Drug product
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
D-0412-2024
Product summary
- Event
- Event 93456
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,508 bags; expanded 1,015 bags
- Official record key
drug-enforcement:D-0412-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: 1223044958 Exp 11/10/23; 1223045436 Exp 11/30/23; 1223046132 Exp 12/28/23; 1223046385 Exp 01/06/24; 1223048807 Exp 04/17/24; 1223049030 Exp 04/26/24 Expanded Recall lots: 1223049328, Exp 05/10/2024;1223048948, Exp 04/21/2024; 1223048631, Exp 04/10/2024; 1223050389, Exp 06/21/2024.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility