SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharm...
FDA Recall #D-0208-2021 — Class II — December 17, 2020
Product Description
SUCccinylcholine Chloride 200 mg/10 mL, (20 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090812
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
3,239 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220023028, BUD 1/19/2021; 1220023124, BUD 1/25/2021; 1220023162, BUD 1/26/2021 & 1220023210, BUD 1/28/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated