FDA recall D-0197-2021

Product

Ketamine 100 mg/10mL in 0.9% Sodium Chloride Injection (10 mg/mL), CII, Rx Only, 10 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004043012

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-0197-2021