D-0201-2021 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- January 13, 2021
- Initiation Date
- December 17, 2020
- Termination Date
- November 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 751 syringes
Product Description
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010025
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Distribution Pattern
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023452, BUD 2/7/2021