FDA recall D-0768-2021
SterRx, LLC · Class II · drug
Product
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide in the US
Key facts
- Status
- Terminated
- Initiation date
- 2021-08-10
- Report date
- 2021-09-01
- Termination date
- 2022-05-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plattsburgh, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0768-2021