Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Testosterone Gel 1%
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Class II · Moderate risk
Desmopressin Acetate Tablets
CGMP Deviations
Class II · Moderate risk
Hydrogen Peroxide Topical Solution USP
Cross Contamination With Other Products: Product is cross contaminated with low levels of isopropyl alcohol.
Class II · Moderate risk
Launch Sequence Aphrodisia Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Euphoria Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Launch Sequence Capsules
Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.
Class II · Moderate risk
Divalproex Sodium Delayed-Release Tablets
Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
Class II · Moderate risk
Hydrogen Peroxide Topical Solution
Labeling: Label Mix-Up-The primary label on the front of the bottles have Hydrogen Peroxide affixed to the front and back of the containers. However, the product inside the bottle is 70% Isopropyl Alcohol.
Class II · Moderate risk
Testosterone Cypionate Injection
cGMP - Water leakage
Class II · Moderate risk
Draximage MAA
Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk
Eszopiclone Tablets
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II · Moderate risk
70% ISOPROPYL ALCOHOL First aid antiseptic
Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class II · Moderate risk
Fluticasone Propionate Nasal Spray
Defective container: defect prevents product from dispensing as intended.
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Estriol 1mg/gm
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg per suppository
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Boric Acid 600 mg capsules
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk
Doxycycline
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
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