Cardinal Health Recalls Potassium Chloride Tablets Due to Incorrect Package Insert
Cardinal Health is recalling specific lots of potassium chloride extended-release tablets because they were packaged with the wrong package insert.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Cardinal Health is recalling 100 blister cards of Potassium Chloride, microencapsulated extended-release tablets, 20 mEq. The affected product was manufactured by Upsher-Smith Laboratories, Inc. for Sandoz, Inc. and repackaged by Cardinal Health. The recall involves two specific lots: Lot # 315004A and Lot # 315620A, both with an expiration date of 1/15/14.
The recall was initiated due to a labeling error. The product was packaged with the package insert for potassium chloride 8 mEq and 10 mEq strengths, rather than the correct insert for the 10 mEq and 20 mEq strengths. This discrepancy could lead to confusion regarding the product's dosage and usage instructions.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. 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 distributor or disposed of according to local regulations.
The recalled product
- Product
- Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated shipper, Rx only, Manufactured by Upsher-Smith Laboratories, Inc. Minneapolis, MN 55447 for Sandoz, Inc., Princeton, NJ 08540 Repackaged by Cardinal Health Zanesvil
- Manufacturer
- Cardinal Health
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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 (3)
- Lot #: 315004A
- Exp 1/15/14
- Lot #: 315620A
Distribution
Distributed in 1 state:
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