Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box, NDC 41520-525-69, UPC 3 41520 31346 2; b) Children's 10-count tablets per box NDC 41520-527-69, UPC 3 41520 31455 1; Distributed by: American Sales Company, 4201 Walden Avenue, Lancaster, NY 14086
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Reason Failed Moisture Limits
Reason Failed Moisture Limits
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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