fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syr...
FDA Recall #D-0192-2021 — Class II — December 17, 2020
Product Description
fentaNYL 100 mcg/50mL Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL, 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals,755 Rainbow Rd., Windsor, CT, 06095, barcode 70004023122
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
996 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220022911, BUD 1/18/2021; 1220023092, BUD 1/25/2021 & 1220023247, BUD 1/27/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated