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.
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 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
- 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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