Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx ...
FDA Recall #D-0211-2021 — Class II — December 17, 2020
Product Description
Rocuronium Br 50 mg/5mL (10 mg/mL), a) 5 mL Single Dose Syringe Red Label(barcode 7000485009) Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095 and b) 5 mL Single Dose Syringe White Label (barcode 70004085028), Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct, Little Rock, AR 72205
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
13,096 syringes
Distribution
Product was distributed to hospitals nationwide.
Code Information
a) Lot # 1220023011, BUD 1/12/2021; 1220023027, BUD 1/19/2021; 1220023151, BUD 1/26/2021; 1220023152, BUD 1/26/2021; 1220023194, BUD 1/26/2021; 1220023228, BUD 1/28/2021; 1220023358. BUD 2/3/2021; 1220023396. BUD 2/3/2021; 1220023398, BUD 2/10/2021; 1220023569, BUD 2/9/2021 & 1220023633, BUD 2/11/2021. b)1220023031, BUD 1/19/2021; 1220023032, BUD 1/24/2021; 1220023161, BUD 1/26/2021 & 1220023224, BUD 1/28/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated