Baxter Recalls Potassium Chloride Injection Bags Due to Labeling Error
Baxter Healthcare is recalling 63,360 bags of Potassium Chloride Injection due to incorrect outer packaging labels indicating a higher strength.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding drug strength, which fits the rubric criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Baxter Healthcare Corp. is recalling 63,360 bags of Potassium Chloride Injection, 10 mEq per 100 mL, 100 mL sterile single dose container bags. The recall is limited to Lot P319160, which has an expiration date of 06/30/15. The product is distributed nationwide.
The recall was initiated because the bags were incorrectly overpouched with wraps labeled as Potassium Chloride Injection, 20 mEq per 100 mL. This labeling error creates a discrepancy between the declared strength on the outer packaging and the actual strength of the solution inside the bag.
Healthcare providers and patients should verify the label on the individual container bag against the lot number and expiration date. If the product matches the recalled lot, it should not be used. Consumers should contact their healthcare provider for guidance on proper disposal or replacement.
The recalled product
- Product
- POTASSIUM CHLORIDE (POTASSIUM CHLORIDE)
- Brand
- POTASSIUM CHLORIDE
- Manufacturer
- Baxter Healthcare Corp.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 63,360
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 #: P319160
- Exp 06/30/15
Distribution
Distributed nationwide across the United States.
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