CLASS II Drug recall · Reported 5 Jan 2022 · FDA Enforcement Report
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx
SterRx is recalling Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per (12.6 mg per mL), distributed nationwide in the US. The recall was initiated on 12 Nov 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0306-2022
- FDA event ID
- 89059
- Recalling firm
- SterRx, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Nov 2021
- FDA classified
- 29 Dec 2021
- Reported
- 5 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 12 Nov 2021 | Recall initiated by company | |
| 29 Dec 2021 | Classified by FDA | +47 days |
| 5 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903, NDC 70324-326-01.
Where it was distributed
U.S.A. Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
S20483/BNJ 23-Nov-21 S20484/BNK 24-Nov-21 S20485/BNL 25-Nov-21 S21008/BNV 3-Dec-21 S21010/BNX 9-Dec-21 S21025/BOM 10-Dec-21 S21026/BON 15-Dec-21 S21027/BOO 16-Dec-21 S21035/BOW 17-Dec-21 S21045/BPF 18-Dec-21 S21046/BPG 21-Dec-21 S21050/BPK 22-Dec-21 S21054/BPO 24-Dec-21 S21055/BPQ 25-Dec-21 S21061/BPW 28-Dec-21 S21062/BPX 29-Dec-21 S21063/BPY 30-Dec-21 S21064/BPZ 31-Dec-21 S21069/BQE 31-Dec-21 S21073/BQI 4-Jan-22 S21074/BQJ 5-Jan-22 S21076/BQL 6-Jan-22 S21077/BQM 7-Jan-22 S21081/BQQ 20-Jan-22 S21083/BQS 22-Jan-22 S21084/BQT 25-Jan-22 S21110/BRU 26-Jan-22 S21111/BRV 27-Jan-22 S21112/BRW 27-Jan-22 S21113/BRX 28-Jan-22 S21114/BRY 1-Feb-22 S21115/BRZ 1-Feb-22 S21123/BSH 2-Feb-22 S21124/BSI 3-Feb-22 S21126/BSK 3-Feb-22 S21127/BSL 4-Feb-22 S21128/BSM 4-Feb-22 S21129/BSN 5-Feb-22 S21168/BTZ 10-Mar-22 S21169/BUA 11-Mar-22 S21176/BUH 15-Mar-22 S21181/BUL 17-Mar-22 S21182/BUM 17-Mar-22 S21270/BXN 26-May-22 S21274/BXR 26-May-22 S21321/BZH 1-Jun-22 S21322/BZI 2-Jun-22 S21323/BZJ 3-Jun-22 S21324/BZK 3-Jun-22 S21325/BZL 7-Jun-22 S21329/BZP 8-Jun-22 S21336/BZW 14-Jun-22 S21337/BZX 15-Jun-22 S21338/BZY 16-Jun-22 S21341/CAB 17-Jun-22 S21343/CAD 18-Jun-22 S21348/CAH 23-Jun-22 S21350/CAJ 24-Jun-22 S21351/CAK 28-Jun-22 S21357/CAQ 1-Jul-22 S21360/CAT 2-Jul-22 S21363/CAW 5-Jul-22 S21366/CAZ 7-Jul-22 S21374/CBH 8-Jul-22 S21376/CBJ 8-Jul-22 S21377/CBK 12-Jul-22 S21381/CBO 13-Jul-22 S21384/CBR 13-Jul-22 S21387/CBU 13-Jul-22 S21390/CBX 14-Jul-22 S21392/CBZ 14-Jul-22 S21393/CCA 15-Jul-22 S21396/CCD 15-Jul-22 S21397/CCF 19-Jul-22 S21399/CCH 19-Jul-22 S21401/CCJ 20-Jul-22 S21404/CCM 21-Jul-22
Where was it sold?
U.S.A. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
25 other products · FDA event 89059This product is part of a recall event; the main page for the event is Morphine Sulfate, in 0.9% Sodium Chloride Injection recalled by SterRx.
More recalls from SterRx
All 35| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Norepinephrine 32 mg per (128 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 8 mg per (32 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 16 mg per (64 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx | SterRx | Sterility | Nationwide |
| Drug | CLASS II | Norepinephrine 4 mg per (16 mcg per mL) recalled by SterRx | SterRx | Sterility | Nationwide |
Other Sodium Bicarbonate recalls
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/ (0.5 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Lead & Heavy Metals | Nationwide |
| Drug | CLASS II | Vial Label: 8.4% Sodium Bicarbonate Injection, USP, 50mEq recalledSodium Bicarbonate | Pfizer | Sterility | Nationwide |
| Drug | CLASS II | 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Exela Pharma Sciences | Sterility | Nationwide |
| Drug | CLASS I | 8.4 % Sodium Bicarbonate Injection, USP 50 mEq/ (1 mEq/mL) recalledSodium Bicarbonate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/ (0.5 mEq/mL) recalled | Pfizer | Particulate Matter | Nationwide |