Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg, packaged in a) 10-count tablets per box (NDC 49348-930-01, UPC 0 1093936544 6); and b) 30-count tablets per box (NDC 49348-930-44, UPC 0 1093934944 6) Distributed by McKesson, One Post Street, San Francisco, CA 94104
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.
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.