Loratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits
Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.
What this means for you
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: This is an FDA Class III recall for a labeling/packaging-related quality defect (failed moisture limits) with no reported illnesses or injuries. Per the rubric, Class III recalls are typically scored 1 or 2, and moisture control issues represent a manufacturing defect rather than an acute safety hazard, warranting a Moderate classification.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) in 10-count blister packs. The recall affects 22,752 blister packs distributed nationwide within the United States.
The recall is due to failed moisture limits. The affected product is Lot #AC14635 with expiration date 12/2022, NDC 0904-5833-15, distributed by Major Pharmaceuticals.
Consumers who have purchased this product should contact their pharmacy or healthcare provider for guidance. Consumers with questions may contact the manufacturer.
The recalled product
- Product
- LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
- Brand
- LORATADINE AND PSEUDOEPHEDRINE SULFATE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- moisture-control-failure
- product-stability
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 (2)
- Lot #: AC14635
- Exp. Date 12/2022
Distribution
Distributed nationwide across the United States.
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