Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
FDA Drug Recalls
1,206 recalls · Class II, newest first
Class II · Moderate risk
Proton Armor
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Class II · Moderate risk
Colgate Whitening Mouthwash
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER…
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Colgate Anticavity Fluoride Toothpaste
cGMP deviation: Product held outside of appropriate temperature storage conditions.
Class II · Moderate risk
Ketorolac Tromethamine Injection
cGMP Deviations: deviations leading to potential cross-contamination.
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
PF-0.125% Bupivacaine HCl Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Trisodium Citrate 0.5% Solution
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
Class II · Moderate risk
Corsair Personal Care 99X Instant Foam Hand Sanitizer
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class II · Moderate risk
Maxim Instant Foam Hand Sanitizer
CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride.
Class II · Moderate risk
Acetaminophen Injection
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
Class II · Moderate risk
Difluprednate Ophthalmic Emulsion 0.05%
Lack of Assurance of Sterility: Complaints received of defective container closure.
Class II · Moderate risk
PrednisoLONE Oral Solution USP
Defective Container: Product has incomplete induction seals.
Class II · Moderate risk
Rifampin Capsules
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
Class II · Moderate risk
Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for…
Lack of Assurance of Sterility
Class II · Moderate risk
Divalproex Sodium Extended Release Tablets
Failed dissolution specifications.
Class II · Moderate risk
fentaNYL Citrate in 0.9% Sodium Chloride
Lack of Assurance of Sterility
Class II · Moderate risk
FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Matzim LA (Diltiazem Hydrochloride)
Failed Dissolution Specifications: below specification limits for dissolution.