PlainRecalls
FDA Drug Moderate Class II Terminated

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

Reported: July 26, 2023 Initiated: July 7, 2023 #D-0930-2023

Product Description

Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.

Reason for Recall

Lack of Assurance of Sterility

Details

Recalling Firm
SterRx, LLC
Units Affected
137,304 bags
Distribution
Nationwide in the USA
Location
Plattsburgh, NY

Frequently Asked Questions

What product was recalled?
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per mL), 1,000 mL Single Dose bag, packaged in 1000 mL x 6 units per case, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.. Recalled by SterRx, LLC. Units affected: 137,304 bags.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on July 26, 2023. Severity: Moderate. Recall number: D-0930-2023.