Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Sy...
FDA Recall #D-0209-2021 — Class II — December 17, 2020
Product Description
Morphine Sulfate 30 mg/30 mL in 0.9% Sodium Chloride (1mg/ml), CII, Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010016
Reason for Recall
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
116 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023412, BUD 2/2/2021; 12220023500, BUD 2/3/2021 & 1220023689 BUD 2/11/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated