Class II · Moderate risk
Haloderm Homeopathic Blend
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Yeast Guard Blend
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Occular Allergy Blend 87% Alcohol
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
ZTE-105 Formula Gentle Detoxing. Contents 1000 mL
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk
Aconitum nap Fear* 87% Alcohol HPUS: 5X
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class III · Low risk
Donepezil HCL Tablets
Subpotent
Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Class II · Moderate risk
Trulicity (dulaglutide)
Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class I · High risk
X Rated Honey for Men
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Class II · Moderate risk
Spironolactone Ophthalmic Solution 0.005 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Carvedilol 25 mg
A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Class II · Moderate risk
Sodium Phenylbutyrate POWDER
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk
Carvedilol Tablets
Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class II · Moderate risk
Sodium Selinite 200mcg/Ml for Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Progesterone 100mg/Ml Mdv Oil Injection
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a/B6 15/50/100 5mg/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic/B12a 25/50/50mg/Ml 1mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Mic 25/50/50mg/Ml Mdv
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk
Methylcobalamin 5000mcg/Ml Mdv Inj
Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns