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
D-0768-2021
Product summary
- Firm
- SterRx, LLC
- Event
- Event 88436
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3378 bags
- Official record key
drug-enforcement:D-0768-2021
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot Numbers: BTW, exp. date 03/08/22 BUI, exp. date 03/16/22
Distribution pattern: Nationwide in the US
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility