Status
Terminated
Drug Enforcement D-0412-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
April 3, 2024
Termination Date
August 27, 2024
Product Information
- Product description
- 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
- Product quantity
- 1,508 bags; expanded 1,015 bags
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- SCA Pharmaceuticals, LLC
- Address
-
755 Rainbow Rd Ste B, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0412-2024
- Event ID
- 93456
- Recall initiation date
- November 9, 2023
- Center classification date
- March 22, 2024
- 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.
- More code info
- —