FDA recall D-0302-2022
SterRx, LLC · Class II · drug
Product
dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-976-01.
Reason for recall
Lack of Assurance of Sterility
Distribution
U.S.A. Nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2021-11-12
- Report date
- 2022-01-05
- Termination date
- 2023-12-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Plattsburgh, NY, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0302-2022