Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
CVS Pharmacy, Original Prescription Strength, LORATADINE ORALLY DISINTEGRATING TABLETS, USP, 10 mg, packaged in a) 10-count tablets per box, Item 876239, UPC 0 50428 61152 4, and b) 30-count tablets per box, Item 367404, UPC 0 50428 11367 7, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895
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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