morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single...
FDA Recall #D-0202-2021 — Class II — December 17, 2020
Product Description
morphine sulfate 150 mg/30 mL in 0.9% Sodium Chloride Injection, (5 mg/mL), Rx Only, 30 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004010316
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
50 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023221, BUD 1/31/2021 & 1220023584, BUD 2/9/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated