FDA recall D-0211-2021

Product

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

Distribution

Product was distributed to hospitals nationwide.

Key facts

Status

Terminated

Initiation date

2020-12-17

Report date

2021-01-13

Termination date

2021-11-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0211-2021