Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
FDA Drug Recalls
14,806 recalls, newest first
Class II · Moderate risk
Bethanechol Chloride 1mg/ml
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Calcipotriene Topical Solution
Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class II · Moderate risk
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Testosterone Cypionate Injection
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Class II · Moderate risk
Zileuton Extended-Release Tablets
Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class I · High risk
SnoreStop NasoSpray
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class II · Moderate risk
Clonidine Transdermal System
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class I · High risk
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ
Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
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.
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.