Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
FDA Drug Recalls
7 recalls · Class III, newest first
Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Class III · Low risk
Pitavastatin Tablets
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
Class III · Low risk
Famciclovir Tablets
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class III · Low risk
Levothyroxine Sodium Tablets
Presence of a foreign substance: black hair found embedded in tablet.
Class III · Low risk
Pregabalin Capsules 50mg
Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class III · Low risk
Tranexamic Acid Injection
Presence of Particulate Matter: Piece of metal found in a vial