VistaPharm Recalls Potassium Chloride Oral Solution Due to Cup Leakage
VistaPharm is recalling 13,609 cases of Potassium Chloride Oral Solution because the unit dose cups may leak at the seal.
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 2/5 (Moderate).
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 the hazard is a packaging defect (leakage) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
VistaPharm, Inc. is recalling 13,609 cases of Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups. The product is identified by NDC 66689-047-01 and NDC 66689-047-50. The recall involves specific lots: 437600 (Exp 07/17) and 447100 (Exp 10/17).
The recall was initiated due to a defective container issue where leakage may occur at the seal of the unit dose cups. This defect could potentially compromise the integrity of the packaging.
The affected product was distributed domestically to the following states: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, and WV. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the supplier or disposed of according to local regulations.
The recalled product
- Product
- Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15 mL unit dose cups (NDC 66689-047-01), 50 unit dose cups per case (NDC 66689-047-50), Rx only, Xact Dose, Manufactured by VistaPharm, Largo, FL 33771.
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Hazard
- Affected units
- 13,609
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 (4)
- Lot #'s: 437600
- Exp 07/17
- 447100
- Exp 10/17
Distribution
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