D-0416-2024 Class II Terminated
FDA drug recall D-0416-2024 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: 1,118 syringes in kits.
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
- 1,118 syringes in kits
Product Description
PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 5 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-11-K, Bar Code 70004081011. (same finished product as F078140, but with RFID for KitCheck
Reason for Recall
Lack of Assurance of Sterility
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: 1223048431 exp 04/05/24; 1223049023 exp 04/25/24
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0416-2024
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026