Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution
Reason Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Memantine Hydrochloride Extended-release Capsules
Reason Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class III · Low risk Terminated
VCF Vaginal Contraceptive Foam
Reason Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Class III · Low risk Terminated
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant &…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48hr Confidence Regular Original Solid Anti-Perspirant &…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48hr Confidence Nourishing Coconut invisible solid…
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Reason Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk Terminated
Timolol Maleate Sterile Opthalmic Solution
Reason Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Class III · Low risk Terminated
Timolol Maleate USP
Reason Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
Class III · Low risk Terminated
Colostat
Reason Labeling mix-up - Indications on product label are incorrect.
Class III · Low risk Terminated
Clobetasol Propionate Foam
Reason Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk Terminated
Clobetasol Propionate Foam
Reason Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class III · Low risk Terminated
Amiodarone Hydrochloride Injection
Reason Crystallization: Presence of visible particulate matter.
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cefdinir for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Cephalexin for Oral Suspension USP
Reason Presence of Foreign substance: identified as a dead ant.
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Presence of Foreign Tablets/Capsules: a single tablet of Pravastatin 40 mg found in bottle of Atorvastatin Calcium 40 mg.
Class III · Low risk Terminated
PF-Succinylcholine Chloride Injection
Reason Incorrect labeling: Incorrect or missing lot and/or exp date
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution 0.5%
Reason Labeling: Incorrect or missing package insert.
Class III · Low risk Terminated
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Reason Labeling: Incorrect or missing package insert.
Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution 0.03%
Reason Labeling: Incorrect or missing package insert.
Class III · Low risk Terminated
Isotretinoin Capsules
Reason Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.