Class II · Moderate risk Terminated
Doxycycline
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Bethanechol Chloride 1mg/ml
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Calcipotriene Topical Solution
Reason Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Class II · Moderate risk Terminated
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
Reason CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Class II · Moderate risk Terminated
Zileuton Extended-Release Tablets
Reason Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
Class I · High risk Terminated
SnoreStop NasoSpray
Reason Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class II · Moderate risk Terminated
Clonidine Transdermal System
Reason Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Class I · High risk Terminated
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ
Reason 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 Terminated
CORRECTDOSE Children's COUGH & CHEST CONGESTION DM
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
CORRECTDOSE Children's PAIN RELIEF & Fever Reducer
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
CORRECTDOSE Children's ALLERGY RELIEF
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Class II · Moderate risk Terminated
GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL
Reason CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
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.
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 I · High risk Terminated
Magnesium Hydroxide 2400 mg
Reason Microbial Contamination of Non-Sterile Products.