Class II · Moderate risk
dilTIAZem HCl 125 mg per 125 mL
Lack of Assurance of Sterility
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Morphine Sulfate in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Midazolam in 0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
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 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 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.
Class II · Moderate risk
Maximum Strength 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.
Class II · Moderate risk
No Drip Nasal Decongestant
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Maximum Strength No Drip Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Maximum Strength No Drip Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.