Recalls / Class II
Class IID-0412-2024
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
- Affected lot / code info
- 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.
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 1,508 bags; expanded 1,015 bags
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-09
- FDA classified
- 2024-03-22
- Posted by FDA
- 2024-04-03
- Terminated
- 2024-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0412-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.