Class II · Moderate risk
PF-Neostigmine Methylsulfate Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
PF-Labetalol HCl Injection
CGMP Deviations: Potential for cross contamination due to product carry over.
Class II · Moderate risk
Phenoxybenzamine Hydrochloride Capsules
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Conzerol zero molluscum contagiosum
CGMP deviations
Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution
cGMP deviation: discontinue of stability support for product.
Class II · Moderate risk
Carvedilol Tablets
Failed Tablet/Capsule Specifications: Tablets exceeds specification for weight and thickness.
Class II · Moderate risk
Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg
Presence of Foreign Substance
Class II · Moderate risk
Rifampin Capsules
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk
Rifampin Capsules
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Class II · Moderate risk
Fondaparinux Sodium Injection
Subpotent Drug: Out of specification for assay
Class II · Moderate risk
Pyridostigmine Bromide Oral Solution
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Class II · Moderate risk
Arformoterol Tartrate Inhalation Solution
Lack of Assurance of Sterility: environmental monitoring failure.
Class II · Moderate risk
Aminophylline Injection
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Class II · Moderate risk
Ampicillin for Injection
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Class II · Moderate risk
Budesonide Inhalation Suspension 0.25mg/2mL
Lack of Assurance of Sterility
Class II · Moderate risk
Lisinopril 10 mg tablets
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Sanitizing Hand Spray 80%
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk
Lisinopril Tablets USP
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Skincell Mole & Skin Corrector Serum
Marketed Without An Approved NDA/ANDA; Unapproved new drug
Class II · Moderate risk
Synergy Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Class II · Moderate risk
Sodium Chloride Ophthalmic Ointment USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.
Class II · Moderate risk
Lidocaine Hydrochloride Jelly USP
cGMP Deviations: Turbidity discovered in Artificial Tears Ointment during sterility testing. Scope expanded to include other lots and products which potentially share the same root cause.