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 NDC 70324-326-01
D-0767-2021
Product summary
- Firm
- SterRx, LLC
- Event
- Event 88436
- Status
- Terminated
- Classification
- Class I
- Quantity
- 1098 bags
- Official record key
drug-enforcement:D-0767-2021
Official wording
Reason: Non-Sterility: firm's third party lab confirmed microbial contamination.
Code information: Lot Number: BUP, exp. date 03/23/22
Distribution pattern: Nationwide in the US
Derived failure modes
-
Microbial contamination
microbial contamination