Drug product
Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-03
D-0325-2022
Product summary
- Firm
- SterRx, LLC
- Event
- Event 89059
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2886 bags
- Official record key
drug-enforcement:D-0325-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: S20459/BMP 17-Nov-21 S20472/BMZ 18-Nov-21 S20473/BNA 18-Nov-21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility