SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 ...

FDA Recall #D-0212-2021 — Class II — December 17, 2020

Recall #D-0212-2021 Date: December 17, 2020 Classification: Class II Status: Terminated

Product Description

SUCcinylcholine Chloride 100 mg/5mL, Rx Only, 5 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., WIndsor, CT, 06095, barcode 70004090809

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

5067 syringes

Distribution

Product was distributed to hospitals nationwide.

Code Information

Lot # 1220023019, BUD 1/17/2021; 1220023025, BUD 1/18/2021; 1220023026, BUD 1/24/2021 & 1220023264, BUD 2/1/2021.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated