SCA Pharmaceuticals, LLC: Drug Recall
Recall #D-0415-2024 · 11/09/2023
Class II: Risk
Recall Details
- Recall Number
- D-0415-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- SCA Pharmaceuticals, LLC
- Status
- Terminated
- Date Initiated
- 11/09/2023
- Location
- Windsor, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,198 syringes; expanded 1,289 syringes
Reason for Recall
Lack of Assurance of Sterility
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, Bar Code 70004081011
Distribution Pattern
Nationwide in the USA
Other Recalls by SCA Pharmaceuticals, LLC
- Class II: Risk 11/09/2023
- Class II: Risk 11/09/2023
- Class II: Risk 11/09/2023
- Class II: Risk 11/09/2023
- Class II: Risk 11/09/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.