FDA Recall D-0767-2021
SterRx, LLC · Plattsburgh, NY
Class I — life-threatening Terminated 282 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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
Reason for recall
Non-Sterility: firm's third party lab confirmed microbial contamination.
Recall record
- Recall number
D-0767-2021- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the US
- Recall initiated
- 2021-08-10
- Classified by FDA Center
- 2021-08-25
- FDA published
- 2021-09-01
- Terminated
- 2022-05-19
- Recalling firm
- SterRx, LLC
- Firm location
- Plattsburgh, NY