FDA recall D-1843-2019

Product

Ketamine 50 mg/5 mL in 0.9% Sodium Chloride Injection for IV or IM Use (concentration = 10 mg/mL), 6 mL Syringe, Rx Only, SCA Pharmaceuticals, Windsor, CT 06095, NDC 70004-0430-09.

Reason for recall

Lack of Assurance of Sterility.

Distribution

Nationwide in the U.S.

Key facts

Status

Terminated

Initiation date

2019-08-16

Report date

2019-08-28

Termination date

2019-10-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Windsor, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1843-2019