The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-243-2013·Announced 2013-04-10

Hospira Recalls 0.9% Sodium Chloride Injection Due to Sterility Concerns

Hospira is recalling 624,240 units of 0.9% Sodium Chloride Injection, USP, 50 mL, due to a lack of assurance of sterility and potential leakage.

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 recall is classified as FDA Class II and involves a lack of assurance of sterility in an injectable product, which poses a risk of serious injury or death, meeting the criteria for a Severe rating.

Plain-English summary

Hospira, Inc. is recalling 624,240 units of 0.9% Sodium Chloride Injection, USP, 50 mL (NDC 0409-7984-36). The affected product is identified by Lot # 22-028-JT with an expiration date of 04/14. The recall is being conducted because the product lot was incorrectly released without meeting product specifications.

The FDA has classified this recall as Class II. The specific issue is a lack of assurance of sterility, with a potential for the solution to leak from the administrative port to the fill tube seal. The product was distributed nationwide.

Healthcare providers and consumers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to standard recall procedures.

The recalled product

Product
0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7984-36 Hospira, Inc., Lake Forest, IL 60045
Manufacturer
Hospira Inc.
Category
Drug — Injectable
Hazard
Affected units
624,240

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 #: 22-028-JT Exp 04/14

Distribution

Distributed nationwide across the United States.

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