D-0394-2024 Class II Terminated
FDA drug recall D-0394-2024 was initiated by SCA Pharmaceuticals, LLC on November 9, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated August 27, 2024). Affected quantity: 381 Bags.
Recall Details
- Product Type
- Drugs
- Report Date
- April 3, 2024
- Initiation Date
- November 9, 2023
- Termination Date
- August 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 381 Bags
Product Description
Diltiazem HCl 125 mg in 0.9% Sodium Chloride Injection (Concentration = 1mg/mL), 125 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095; NDC 70004-0541-35, Bar Code 70004054135
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223049625, Exp 1/24/24