Hospira Recalls Potassium Chloride Injection Bags Due to Chemical Contamination
Hospira Inc. is recalling 81,888 bags of Potassium Chloride Injection due to potential contamination with an aromatic hydrocarbon resin.
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, which corresponds to a Severe severity score (4) under the rubric, as it involves a potential chemical contamination that could cause temporary or medically reversible health consequences.
Plain-English summary
Hospira Inc. is recalling 81,888 bags of Potassium Chloride Injection 20 mEq, 400 mEq/L, packaged in 50 mL bags (NDC 0409-7077-14). The recall is due to a potential chemical contamination involving an aromatic hydrocarbon resin.
The affected product is identified by Lot Number 53-006-JT and has an expiration date of 11/16. The product was distributed nationwide in the United States and in Singapore.
This is a prescription-only medication. Healthcare facilities and pharmacies should stop using the affected product and contact Hospira Inc. for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 81,888
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 (2)
- Lo# 53-006-JT
- Exp 11/16
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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.
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