Class III · Low risk Terminated
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Reason Failed dissolution specifications
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Allergy & Congestion Relief Allergy Relief D
Reason Failed dissolution specifications
Class III · Low risk Terminated
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Buprenorphine HCl
Reason Crystallization; identified as Buprenorphine free base
Class II · Moderate risk Terminated
Hand Sanitizer Foam
Reason Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class II · Moderate risk Terminated
Clindamycin and Benzoyl Peroxide Gel
Reason Superpotent Drug
Class II · Moderate risk Terminated
Flocinolone Acetonide 0.01% Topical Oil
Reason Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk Terminated
Flocinolone Acetonide 0.01% Topical Oil
Reason Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk Terminated
Cefixime Capsules 400 mg
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Acetaminophen Oral Suspension
Reason cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk Terminated
Acetaminophen Oral Suspension
Reason cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk Terminated
VANComycin 1g added to 250mL of 0.9% Sodium Chloride
Reason Crystallization: Product appears to be turbid.
Class III · Low risk Terminated
Clonidine Transdermal System
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Cartia XT
Reason Labelling: Incorrect Exp. Date
Class II · Moderate risk Terminated
artnaturals Hand Sanitizer
Reason CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Class II · Moderate risk Terminated
artnaturals hand sanitizer
Reason CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Class I · High risk Terminated
artnaturals hand sanitizer
Reason Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
Class II · Moderate risk Terminated
Maximum Strength Nasal Spray
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Maximum Strength Nasal Spray
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Sinus Severe
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
No Drip Nasal Spray
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
No Drip Nasal Spray
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
Maximum Strength No Drip Nasal Spray
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
No Drip Nasal Spray
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk Terminated
No Drip Nasal Decongestant
Reason CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.