Baxter Recalls Potassium Chloride Bags Due to Mispackaging Error
Baxter Healthcare is recalling 148,632 bags of Potassium Chloride Injection because shipping cartons were incorrectly labeled and contained Gentamicin Sulfate Injection instead.
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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving significant injury/property-damage reports or high-risk scenarios, though the rubric explicitly maps Class II to Severe in the context of significant risk or hospitalization reports, or generally as a high-risk category above High.
Plain-English summary
Baxter Healthcare Corp is recalling 148,632 bags of Potassium Chloride Injection, 10 mEq per 100 mL, Highly Concentrated (100 mEq/L), 100 mL Sterile single dose container bags. The product is identified by product code 2B0826, NDC 0338-0709-48, Lot P318220, and expiration date 05/31/15. The recall is due to a mispackaging error where shipping cartons labeled as containing Potassium Chloride injection actually contained bags labeled and containing Gentamicin Sulfate injection inside.
The affected product was distributed nationwide. This recall is classified as FDA Class II, which indicates 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.
Healthcare providers and patients should check their inventory for the specific lot and expiration date listed above. If the product is found, it should be quarantined and not used. Baxter Healthcare Corp is the recalling firm responsible for this action.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp
- Category
- Drug — Injection
- Affected units
- 148,632
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)
- Lot P318220
- EXP 05/31/15
Distribution
Distributed nationwide across the United States.
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