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
Summary
The FDA issued a Class I for Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg per m by SterRx, LLC. Reason: Non-Sterility: firm's third party lab confirmed microbial contamination..
Details
Source
Drug Recall
External ID
D-0767-2021
Action Date
2021-09-01
Status
Terminated
Category
drug
Product Description
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
Lot/Code Info: Lot Number: BUP, exp. date 03/23/22
Quantity Affected: 1098 bags
Reason for Recall
Non-Sterility: firm's third party lab confirmed microbial contamination.
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-10
Company
Plattsburgh, NY
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 58 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
SterRx, LLC has 35 FDA actions in our database, including 35 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SterRx, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SterRx, LLC have FDA actions?
SterRx, LLC has 35 FDA actions in our database, including 35 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0767-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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