Class II · Moderate risk
Fgl, 10 Mg/Ml
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Cjc-1295
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Class III · Low risk
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Labelling: Missing label.
Class I · High risk
Anagrelide Capsules
Failed Dissolution Specifications
Class II · Moderate risk
Lavar 70 Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
Class II · Moderate risk
UVT World Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
Class II · Moderate risk
Health & Hand Gel Hand Sanitizer 70% Alcohol Content
Subpotent drug
Class II · Moderate risk
Class II · Moderate risk
+Protec Hands Antibacterial Gel Topical Solution Instant…
Subpotent drug
Class II · Moderate risk
Tizanidine Tablets
Failed Dissolution Specifications; Out of Specification (low) results were obtained.
Class II · Moderate risk
Cephalexin for Oral Suspension
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
Human Chorionic Gonadotropin 1
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 5
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Class III · Low risk
Fentanyl
Subpotency: Out-of-specification stability test result for low potency was obtained.
Class III · Low risk
Scandonest 3% Plain
Labeling: Label mix-up
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%.