PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Reported: April 3, 2024 Initiated: November 9, 2023 #D-0417-2024
Product Description
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Units Affected
- 5,948 syringes, expanded 2,102 syringes
- Distribution
- Nationwide in the USA
- Location
- Windsor, CT
Frequently Asked Questions
What product was recalled? ▼
PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentration = 100 mcg/mL), 50 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0810-22, Bar Code 70004081022.. Recalled by SCA Pharmaceuticals, LLC. Units affected: 5,948 syringes, expanded 2,102 syringes.
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-0417-2024.
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