Class II · Moderate risk Terminated
Health & Hand Gel Hand Sanitizer 70% Alcohol Content
Reason Subpotent drug
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent
Reason Subpotent drug
Class II · Moderate risk Terminated
+Protec Hands Antibacterial Gel Topical Solution Instant…
Reason Subpotent drug
Class II · Moderate risk Terminated
Tizanidine Tablets
Reason Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Class II · Moderate risk Terminated
Cephalexin for Oral Suspension
Reason Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 1
Reason CGMP deviations: Lack of potency testing.
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 Completed
Kollidon CL-M Crospovidone Ph.Eur.Type B
Reason Cross contamination: the excipient was found to be contaminated with theophylline.
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