Class II · Moderate risk Terminated
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Diphenhydramine HCl Oral Solution
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Calcium Carbonate Oral Suspension
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Acetaminophen Oral Solution 650 mg / 20.3 mL
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Acetaminophen Oral Solution
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Acetaminophen Oral Solution 160 mg / 5 mL
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Magnesium Hydroxide 2400 mg
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Magnesium Hydroxide 1200 mg
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Milk of Magnesia USP
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Milk of Magnesia USP
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Class II · Moderate risk Terminated
Clonazepam Orally Disintegrating Tablets
Reason Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Class II · Moderate risk Completed
Artri King Reforzado con Ortiga Omega 3 Tablets
Reason Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class II · Moderate risk Completed
Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets
Reason Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
Class II · Moderate risk Terminated
Earache Drops
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
Homeopathic EarAche Ear Drops
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
Homeopathic EarAche Drops
Reason Microbial contamination of non-sterile product.
Class II · Moderate risk Terminated
B-Complex + Chromic Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Ethanol for Injection 95%
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Losartan Potassium Tablets
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits