D-0421-2024 Class II Terminated
FDA drug recall D-0421-2024 was initiated by SCA Pharmaceuticals, LLC on Nov 9, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated Aug 27, 2024). Affected quantity: 2,427 syringes.
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 3, 2024
- Initiation Date
- Nov 9, 2023
- Termination Date
- Aug 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,427 syringes
Product Description
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID for KitCheck compatibility)
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223048610 Exp 04/10/24; 1223048611 Exp 04/10/24; 1223048726 Exp 04/13/24; 1223050163 Exp 06/12/24
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0421-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026