Kirkland Signature AllerClear D 24 HR Tablets Recalled for Moisture Failure
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Kirkland Signature AllerClear D 24 HR (Loratadine and Pseudoephedrine Sulfate) tablets nationwide because the product failed to meet moisture content limits.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard—moisture content outside acceptable limits—is a manufacturing specification issue without documented harm to consumers, consistent with a Low severity rating.
Plain-English summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Kirkland Signature AllerClear D 24 HR extended-release tablets containing 10 mg loratadine and 240 mg pseudoephedrine sulfate. The recall affects 46,584 blister packs distributed nationwide within the United States. The product is being recalled due to failed moisture limits during manufacturing quality control.
This is an FDA Class III recall. Consumers who have purchased this product should stop use. The affected product has NDC 63981-724-15 and lot code AC09723 with an expiration date of 11/2022. For more information, consumers may contact the FDA or the recalling manufacturer.
The recalled product
- Product
- KIRKLAND SIGNATURE ALLERCLEAR D 24 HR (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
- Brand
- KIRKLAND SIGNATURE ALLERCLEAR D 24 HR
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Affected units
- 46,584
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)
- AC09723
- Exo
- Date 11/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SUN PHARMACEUTICAL INDUSTRIES INC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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