Hospira Recalls Potassium Chloride Vials Due to Particulate Matter
Hospira is recalling 255,900 vials of Potassium Chloride for Injection due to the presence of red and black particulate matter identified as iron oxide.
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 classification is FDA Class II, which corresponds to a 'Severe' rating (score 4) under the rubric, particularly given the presence of foreign particulate matter in an injectable medication.
Plain-English summary
Hospira Inc. is voluntarily recalling 255,900 vials of Potassium Chloride for Injection Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial. The recall was initiated because red and black particulate matter was identified within the solution and embedded within the plastic vial. The particulate has been identified as iron oxide.
The affected product is Lot 22-127-DK, which was distributed nationwide. The product is a prescription-only medication intended for intravenous use. No specific dates of distribution or specific facilities affected are listed in the source text.
Healthcare providers and patients should stop using the affected product and contact Hospira Inc. for further instructions or a replacement. Consumers should not attempt to use the recalled vials.
The recalled product
- Product
- Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Single-dose Fliptop Vial, For IV use, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injectable Medication
- Affected units
- 255,900
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 22-127-DK
Distribution
Distributed nationwide across the United States.
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