D-0363-2023 Class III Terminated
FDA drug recall D-0363-2023 was initiated by SCA Pharmaceuticals on February 24, 2023 and is designated Class III. Reason for recall: Subpotent Drug The recall status is terminated (terminated June 21, 2023). Affected quantity: 2125 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 24, 2023
- Termination Date
- June 21, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2125 syringes
Product Description
Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor CT 06095, NDC# 70004-0200-16.
Reason for Recall
Subpotent Drug
Distribution Pattern
Nationwide in the US.
Code Information
Lot # 1222043351, exp. date 03/29/2023 1222043387, exp. date 04/05/2023 1222043352, exp. date 04/05/2023 1222043463, exp. date 04/06/2023 1223043922, exp. date 05/04/2023