Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride (1mg/mL) CII, Rx Only, 3 ml Single Dose Syring...
FDA Recall #D-0201-2021 — Class III — December 17, 2020
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
Recalling Firm
SCA Pharmaceuticals — Windsor, CT
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
751 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023452, BUD 2/7/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated