The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-316-2013·Announced 2013-05-15

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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 →

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