FDA Recall Terminated Historical recordClass II
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride (100 mcg/mL), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004081011
- Reason
- Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
- Published
- January 13, 2021
- Distribution
- Nationwide
