CLASS II Drug recall · Reported 1 Sep 2021 · 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 10 Aug 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-0768-2021
- FDA event ID
- 88436
- Recalling firm
- SterRx, Plattsburgh, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Aug 2021
- FDA classified
- 25 Aug 2021
- Reported
- 1 Sep 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Aug 2021 | Recall initiated by company | |
| 25 Aug 2021 | Classified by FDA | +15 days |
| 1 Sep 2021 | 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 1,000 mL (12.6 mg per mL), 1,000 mL bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Lot Numbers: BTW, exp. date 03/08/22 BUI, exp. date 03/16/22
Where was it sold?
Nationwide in the US
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
1 other product · FDA event 88436This product is part of a recall event; the main page for the event is Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq recalled by SterRx | SterRx | Sterility | Nationwide |
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 |