SCA Pharmaceuticals: Drug Recall
Recall #D-0196-2021 · 12/17/2020
Class II: Risk
Recall Details
- Recall Number
- D-0196-2021
- 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
- 1,056 syringes
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Product Description
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection (1 mg/mL) a) 30 mL Plungerless Single Dose Syringe (barcode 70004030316) and b) 30 mL Single Dose Syringe (barcode 70004030321), Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095
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.