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Out of specification (OOS) for Spectroscopic Identification test by IR.
CGMP Deviations: recalling drug products following an FDA inspection.
This recall involves prescription drugs Nurtec ODT 75 mg orally disintegrating tablets sold in cartons containing one blister card of 8 tablets. The tablets are in a non-child resistant blister card packaged in a carton that includes the name of the product, dosage strength, expiration date. The dosage strength and expiration date are printed or stamped on the blister card. The recall includes the following: Product Description NDC Number Expiration Date Nurtec® ODT (rimegepant) 75mg 8-Unit Dose blister pack 72618-3000-2 All dates through 6/2026
CGMP Deviations
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Labeling; Incorrect NDC number on outer carton of product.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
CGMP Deviations: Discoloration
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
cGMP deviations