Hospira Recalls Sodium Acetate Injection Due to Sterility Concerns
Hospira Inc. is recalling 266,900 vials of Sodium Acetate Injection due to loose crimps that may compromise sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as sterility issues in IV drugs) are categorized as Severe (Score 4), as they are not Class I but involve significant risk.
Plain-English summary
Hospira Inc. is recalling 266,900 vials of Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop. The recall affects Lot 23-320-DK and 23-321-DK with an expiration date of 11/14. The product is distributed nationwide and in Puerto Rico.
The recall is being conducted because of a lack of assurance of sterility. Specifically, a loose crimp was applied to the fliptop vial, which may allow contamination. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions or a replacement. The product is a prescription-only intravenous medication.
The recalled product
- Product
- SODIUM ACETATE (SODIUM ACETATE)
- Brand
- SODIUM ACETATE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 266,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 23-320-DK and 23-321-DK Exp. 11/14
Distribution
Part of a larger recall action
This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same brand · SODIUM ACETATE
- SevereFresenius Kabi Sodium Acetate Injection Recalled for Particulate Matter
FDA (Drugs) · 2022-03-30
Same manufacturer · Hospira Inc.
See all →- CriticalHospira Recalls Dextrose Injection Syringes Due to Human Hair Particulate
FDA (Drugs) · 2017-05-31
- ModerateHospira Recalls Minibore Extension Sets Due to Solvent Occlusion
FDA (Devices) · 2017-01-18
- LowHospira Recalls Lidocaine and Dextrose Injection for Stability Failures
FDA (Drugs) · 2016-12-14
- SevereHospira Recalls Fentanyl Citrate Injection Ampules Due to Broken Tips
FDA (Drugs) · 2016-11-30
- HighHospira Symbiq Infusion Pump Recall for White Screen Safety Shutdown
FDA (Devices) · 2016-11-16
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29