Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 88...
FDA Recall #D-0206-2021 — Class II — December 17, 2020
Product Description
Rocuronium Br 100 mg/10mL (10 mg/mL), Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR, 72205, barcode 70004085012
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
7,940 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
Lot # 1220022998, BUD 1/21/2021; 1220023115, BUD 1/25/2021; 1220023163, BUD 1/26/2021; 1220023186, BUD 1/27/2021; 1220023234, BUD 1/31/2021; 1220023393, BUD 2/3/2021; 1220023477, BUD 2/4/2021; 1220023568, BUD 2/9/2021 & 1220023625, BUD 2/11/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated