Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent and Superpotent Drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent and Superpotent Drug
Class II · Moderate risk Ongoing
Duloxetine DR Capsules USP 60 mg
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Terminated
Lisinopril Tablets
Reason Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Class II · Moderate risk Ongoing
Umary Acid Hyaluronic
Reason cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Class II · Moderate risk Terminated
Henry Schein
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk Terminated
Ipana
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk Terminated
Quala Dental Products
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk Terminated
safco
Reason CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.