Class II · Moderate risk
Desloratadine Tablets USP 5mg a) 100 count
CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
FDA Drug Recalls
2 recalls, newest first
Class II · Moderate risk
Metformin hydrochloride Extended-Release Tablets
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.