CLASS II Drug recall · Reported 15 May 2013 · FDA Enforcement Report
Sodium Acetate Injection, USP, 40 mEq recalled by Hospira
Hospira is recalling Sodium Acetate Injection, USP, 40 mEq/ (2 mEq/mL) Single-Dose Fliptop, distributed nationwide in the US. The recall was initiated on 26 Feb 2013 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-316-2013
- FDA event ID
- 65077
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Sodium Acetate
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Feb 2013
- FDA classified
- 6 May 2013
- Reported
- 15 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Feb 2013 | Recall initiated by company | |
| 6 May 2013 | Classified by FDA | +69 days |
| 15 May 2013 | 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
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
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 Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Which lots are affected?
Lot 23-320-DK and 23-321-DK Exp. 11/14
Where was it sold?
Nationwide and Puerto Rico
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
3 other products · FDA event 65077This product is part of a recall event; the main page for the event is Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalledDiazepam | Hospira | Sterility | Nationwide | |
| CLASS II | Furosemide Injection, USP, 40 mg/ (10 mg/mL) Single-Dose Vial recalledFurosemide | Hospira | Sterility | Nationwide | |
| CLASS II | Quelicin (succinylcholine chloride) Injection, USP, 200 mg recalledQuelicin | Hospira | Sterility | Nationwide |
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
Other Sodium recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Sodium Citrate 4%, Anticoagulation Solution Injection recalled | SCA Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS I | Sodium Acetate Injection, USP, 400 mEq / (4 mEq / mL) recalledSodium Acetate | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS II | Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. vial recalled | KRS Global Biotechnology | Sterility | Nationwide |
| Drug | CLASS II | Sodium Citrate 4%, 40 mg/mL syringe, Flush Syringe, Made recalled | CMC Enterprise Pharmacy | Sterility | NC |