Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Irinotecan Hydrochloride Injection
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
CVS Health Hydrating Healing Ointment
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Immune Boost with natural strawberry flavor
Marketed without an Approved NDA/ANDA: Product marketed with drug claims.
Class II · Moderate risk
Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
TopCare Health
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Best Choice
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
RiteAid Pharmacy RIngworm Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kroger Jock Itch Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kroger Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kaiser Permanente Clotrimazole Cream USP
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
H-E-B - Athlete's Foot Cream Clotrimazole Cream USP
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Equate Athlete's Foot
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
CVS Health Athlete's Foot Cream
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Class II · Moderate risk
Kollidon CL-M Crospovidone Ph.Eur.Type B
Cross contamination: the excipient was found to be contaminated with theophylline.
Class II · Moderate risk
Aripiprazole Tablets
FAILED DISSOLUTION SPECIFICATIONS: Possibility of out-of-specification (OOS) dissolution limits for the remaining shelf life of the Aripiprazole Tablets
Class II · Moderate risk
Aripiprazole Tablets
Failed Dissolution Specifications: Out of specification for dissolution.
Class II · Moderate risk
Levetiracetam Tablets
Presence of foreign tablet/capsule: A 1000 mg Levetiracetam Tablet was found in 500 gram bottle of Levetiracetam Tablets.
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP
Failed Tablet/Capsule Specification
Class II · Moderate risk
Sodium Chloride Injection
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
Metformin HCl Extended Release Tablets USP 500 mg
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Mesalamine Delayed-Release Tablets
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.