SCA Pharmaceuticals: Drug Recall
Recall #D-0197-2021 · 12/17/2020
Class II: Risk
Recall Details
- Recall Number
- D-0197-2021
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- SCA Pharmaceuticals
- Status
- Terminated
- Date Initiated
- 12/17/2020
- Location
- Windsor, CT, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,075 syringes
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product Description
Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012
Distribution Pattern
Product was distributed to hospitals nationwide.
Other Recalls by SCA Pharmaceuticals
- Class II: Risk 07/20/2023
- Class III: Low Risk 04/10/2023
- Class III: Low Risk 02/24/2023
- Class II: Risk 04/25/2022
- Class II: Risk 04/25/2022
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.