Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg, 10-count tablets per box, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, NDC 63868-157-10, UPC 6 35515 95777 0
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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