SKY Aspirin Chewable Tablets Recalled for Incorrect Outer Carton Labeling
McKesson Packaging Services is recalling SKY Aspirin Chewable Tablets because the outer cartons were incorrectly labeled. The recall addresses a labeling mix-up.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for packaging or documentation issues.
Plain-English summary
McKesson Packaging Services is recalling SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, NDC 63739-434-01. The recall involves 1,676 boxes of Lot 0110701 that were distributed nationwide.
The recall was initiated due to a labeling mix-up where the outer cartons were incorrectly labeled as aspirin chewable tablets. 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 who have this product should stop using it and contact McKesson Packaging Services or their healthcare provider for further instructions.
The recalled product
- Product
- SKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
- Manufacturer
- Mckesson Packaging Services
- Hazard
- Affected units
- 1,676
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 0110701
Distribution
Distributed nationwide across the United States.
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