neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceut...
FDA Recall #D-0203-2021 — Class II — December 17, 2020
Product Description
neostigmine methylsulfate 5 mg/5 mL, (1mg/ml), Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004075009
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
390 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023044, BUD 1/30/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated