Recalls / Class I
Class ID-0767-2021
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Affected lot / code info
- Lot Number: BUP, exp. date 03/23/22
Why it was recalled
Non-Sterility: firm's third party lab confirmed microbial contamination.
Recalling firm
- Firm
- SterRx, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 141 Idaho Ave, N/A, Plattsburgh, New York 12903-3987
Distribution
- Quantity
- 1098 bags
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2021-08-10
- FDA classified
- 2021-08-25
- Posted by FDA
- 2021-09-01
- Terminated
- 2022-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0767-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.