Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS
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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