Class III · Low risk
12 HR Allergy & Congestion Relief Fexofenadine HCl
Failed dissolution specifications
FDA Drug Recalls
1,058 recalls, newest first
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Antihistamine & Nasal Decongestant
Failed dissolution specifications
Class III · Low risk
Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended…
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Relief Allergy Relief D
Failed dissolution specifications
Class III · Low risk
Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl…
Failed dissolution specifications
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
Hand Sanitizer Foam
Defective Container: Customer complaints for leaking bottles and dispensing issues.
Class II · Moderate risk
Clindamycin and Benzoyl Peroxide Gel
Superpotent Drug
Class II · Moderate risk
Flocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk
Flocinolone Acetonide 0.01% Topical Oil
Subpotent Drug: Out-of-specification assay result was obtained for Fluocinolone Acetonide.
Class II · Moderate risk
Cefixime Capsules 400 mg
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
Acetaminophen Oral Suspension
cGMP Deviations: Product manufactured with contaminated raw ingredient.
Class II · Moderate risk
VANComycin 1g added to 250mL of 0.9% Sodium Chloride
Crystallization: Product appears to be turbid.
Class III · Low risk
Clonidine Transdermal System
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Cartia XT (Diltiazem Hydrochloride Extended-Release Capsules, USP)
Labelling: Incorrect Exp. Date
Class II · Moderate risk
artnaturals Hand Sanitizer
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Class II · Moderate risk
artnaturals hand sanitizer
CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
Class I · High risk
artnaturals hand sanitizer
Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Sinus Severe
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
No Drip Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
No Drip Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.