D-0399-2024 Class II Terminated
FDA drug recall D-0399-2024 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: 324 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
- 324 syringes
Product Description
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223049125, Exp 12/04/23