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
Reported: April 3, 2024 Initiated: November 9, 2023 #D-0416-2024
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
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 1,118 syringes in kits
- Distribution
- Nationwide in the USA
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by SCA Pharmaceuticals, LLC. Units affected: 1,118 syringes in kits.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 3, 2024. Severity: Moderate. Recall number: D-0416-2024.
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