Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 1
Reason CGMP deviations: Lack of potency testing.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 5
Reason CGMP deviations: Lack of potency testing.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 6
Reason CGMP deviations: Lack of potency testing.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 11
Reason CGMP deviations: Lack of potency testing.
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Class II · Moderate risk Terminated
CVS Health Hydrating Healing Ointment
Reason Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Terminated
Immune Boost with natural strawberry flavor
Reason Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class II · Moderate risk Terminated
Athlete's Foot Cream
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
TopCare Health
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
Best Choice
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
RiteAid Pharmacy RIngworm Cream
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
Kroger Jock Itch Cream
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
Kroger Athlete's Foot Cream
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
Kaiser Permanente Clotrimazole Cream USP
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
Equate Athlete's Foot
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
CVS Health Athlete's Foot Cream
Reason Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk Terminated
Levetiracetam Tablets
Reason Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk Terminated
clomiPRAMINE Hydrochloride Capsules USP
Reason Failed Tablet/Capsule Specification
Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class II · Moderate risk Terminated
Metformin HCl Extended Release Tablets USP 500 mg
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Mesalamine Delayed-Release Tablets
Reason Failed Dissolution Specifications