Recalling firm
SCA Pharmaceuticals, LLC
Product type
Drug
Status
Terminated
Report date
2024-04-03
Distribution
Nationwide in the USA
Firm state
CT
Product quantity
1,508 bags; expanded 1,015 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental MonitoringReason for recall
Lack of Assurance of Sterility
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
Code / lot 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.
Other recalls SPEQ maps to Environmental Monitoring
See all Environmental Monitoring recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.