CLASS I ONGOING Drug recall · Reported 1 Jun 2016 · FDA Enforcement Report
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL) (84 mg/mL) recalled
Hospira is recalling 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL) (84 mg/mL), distributed nationwide in the US. The recall was initiated on 18 Mar 2016 and the FDA has classified it as Class I.
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-0865-2016
- FDA event ID
- 73653
- Recalling firm
- Hospira, Lake Forest, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 18 Mar 2016
- FDA classified
- 23 May 2016
- Reported
- 1 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 18 Mar 2016 | Recall initiated by company | |
| 23 May 2016 | Classified by FDA | +66 days |
| 1 Jun 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Product as listed by the FDA
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Which lots are affected?
Lot # 56-148-EV, Exp 8/1/2017
Where was it sold?
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
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| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
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| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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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 |