Class III · Low risk
Proparacaine Hydrochloride Ophthalmic Solution
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
FDA Drug Recalls
151 recalls · Class III, newest first
Class III · Low risk
PCA Skin Blemish Control Bar
Superpotent Drug: Salicylic acid content is above the firm's specification.
Class III · Low risk
Class III · Low risk
Class III · Low risk
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Bimatoprost Ophthalmic Solution
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Class III · Low risk
Memantine Hydrochloride Extended-release Capsules
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class III · Low risk
Moxifloxacin Ophthalmic Solution USP
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Class III · Low risk
VCF Vaginal Contraceptive Foam
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Class III · Low risk
SURE 48hr Confidence Unscented Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Regular Original Solid Anti-Perspirant & Deodorant Net Wt 2.7 oz
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48hr Confidence Nourishing Coconut invisible solid…
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
SURE 48 hr Confidence Unscented invisible solid Anti-Perspirant & Deodorant
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Class III · Low risk
Timolol Maleate Sterile Opthalmic Solution
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
Timolol Maleate USP
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
Colostat
Labeling mix-up - Indications on product label are incorrect.
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk
Clobetasol Propionate Foam
Defective delivery system; product is not foaming or is coming out as liquid.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Amiodarone Hydrochloride Injection
Crystallization: Presence of visible particulate matter.
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cefdinir for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.
Class III · Low risk
Cephalexin for Oral Suspension USP
Presence of Foreign substance: identified as a dead ant.