Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
FDA Drug Recalls
4 recalls · Class I, newest first
Class I · High risk
PHENYLephrine 1 mg/10 mL
Labeling: Label Error on Declared Strength. Product has correct label on the syringe and the case but some units are incorrectly labeled as .4 mg/10 mL (40 mcg/ml) on the light protective overwrap of each syringe.
Class I · High risk
Cap-Biotin 100 Mg
Labeling: Label Mix-Up: Products labeled Biotin 100 mg found to contain 4-aminopyridine
Class I · High risk
Magnesium Sulfate in Water for Injection
Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.