Class II · Moderate risk Terminated
Bi-Mix Injection
Reason Lack of Assurance of Sterility
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Bi-Mix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bi-Mix Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bacteriostatic Water for Injection 10 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Beta-complex B-1
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ascorbic Acid 500 mg/mL Solution Pharm D Solutions
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Arginine Injections 100 mcg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Acetylcysteine Injection 10 mg/5 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Actoplus met XR
Reason Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Terminated
Minivelle
Reason Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter…
Reason cGMP Deviation
Class II · Moderate risk Terminated
Synjardy
Reason Cross Contamination With Other Products:
Class II · Moderate risk Terminated
Tizanidine HCl Tablets
Reason Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class II · Moderate risk Terminated
Arthritis Pain Relief Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Colds & Flu Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Allergy & Hay Fever Relief Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Muscle & Joint Pain Relief Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Diarrhea Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Sore Throat & Laryngitis Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Sinus Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
Skin Irritation & Itch Response Homeopathic Formula
Reason CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class II · Moderate risk Terminated
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel
Reason CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.