Cetirizine Hydrochloride 10 mg Tablets Labeling Error Recall
A-S Medication Solutions LLC is recalling Cetirizine hydrochloride 10 mg tablets due to a labeling error: bottles were labeled as 90-count when they actually contain 30 tablets.
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: This is a labeling discrepancy involving tablet count without any reported safety hazard, injury, or illness. The source text classifies this as "Not Elsewhere classified" and the FDA classification is Class III, making this a packaging/labeling documentation issue that constitutes a Low severity recall.
Plain-English summary
A-S Medication Solutions LLC is recalling Cetirizine hydrochloride 10 mg tablets due to incorrect labeling. The product was relabeled as a 90-count bottle despite containing only 30 tablets from the manufacturer.
The affected product is Cetirizine hydrochloride 10 mg tablets in 90-count bottles, manufactured by Major Pharmaceuticals (Livonia, MI) and distributed by A-S Medication Solutions (Libertyville, IL). The recalled lot number is 1256330, with 72 bottles distributed across Florida, Indiana, Minnesota, and Wisconsin. The product NDC is 50090-5510-3.
Consumers who have purchased this product should verify the actual tablet count in their bottle matches the label. If the bottle is labeled as 90 tablets but contains fewer tablets, it should not be used. Consumers with questions should contact A-S Medication Solutions.
The recalled product
- Product
- CETIRIZINE (CETIRIZINE HYDROCHLORIDE)
- Brand
- CETIRIZINE
- Manufacturer
- A-S Medication Solutions LLC.
- Hazard
- Affected units
- 72
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 #: 1256330
Distribution
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