Class II · Moderate risk
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
CORRECTDOSE Children's ALLERGY RELIEF
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Diphenhydramine HCl Oral Solution
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Calcium Carbonate Oral Suspension
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 650 mg / 20.3 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Acetaminophen Oral Solution 160 mg / 5 mL
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Magnesium Hydroxide 2400 mg
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Magnesium Hydroxide 1200 mg
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk
Milk of Magnesia USP
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class I · High risk
Magnesium Hydroxide 2400 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Magnesium Hydroxide 1200 mg
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products.
Class I · High risk
Milk of Magnesia USP
Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Testosterone Cypionate Injection
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Class II · Moderate risk
Clonazepam Orally Disintegrating Tablets
Failed Tablet/Capsule Specification; oversized tablet found in a bottle
Class II · Moderate risk
Testosterone Cypionate Injection
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.