D-0403-2024 Class II Terminated
FDA drug recall D-0403-2024 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: 500 syringes.
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
- 500 syringes
Product Description
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223048959, Exp 12/11/23; 1223049009, Exp 12/12/23; 1223049170, Exp 12/20/23; 1223049245, Exp 12/22/23