FDA recall D-0206-2021

Product

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

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-0206-2021