Class II · Moderate risk Terminated
Haloderm Homeopathic Blend
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
FDA Drug Recalls
11,815 recalls · Class II, newest first
Class II · Moderate risk Terminated
Yeast Guard Blend
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Occular Allergy Blend 87% Alcohol
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
ZTE-105 Formula Gentle Detoxing. Contents 1000 mL
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Aconitum nap Fear* 87% Alcohol HPUS: 5X
Reason Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Class II · Moderate risk Terminated
Oxycodone Hydrochloride Tablets
Reason Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Class II · Moderate risk Terminated
Trulicity
Reason 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 II · Moderate risk Terminated
Spironolactone Ophthalmic Solution 0.005 mg/mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Carvedilol 25 mg
Reason 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 Terminated
Betamethasone Dipropionate Lotion USP
Reason Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Class II · Moderate risk Terminated
Sodium Phenylbutyrate POWDER
Reason Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class II · Moderate risk Terminated
Carvedilol Tablets
Reason Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were found in the bottle
Class II · Moderate risk Terminated
Sodium Selinite 200mcg/Ml for Inj
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Progesterone 100mg/Ml Mdv Oil Injection
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Mit/B12 25/50/50mg/Ml 1mg/Ml Mdv
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Mic/B12a/B6 15/50/100 5mg/50mg/Ml Mdv
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Mic/B12a 25/50/50mg/Ml 1mg/Ml Mdv
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Mic 25/50/50mg/Ml Mdv
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Methylcobalamin 5000mcg/Ml Mdv Inj
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Methylcobalamin 12.5mg/Ml Mdv Inj Soln
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Methylcobalamin 1000mcg/Ml Mdv Inj
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Methylcobalamin 10
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Folic Acid 10mg/Ml Mdv Inj
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Calcium Gluconate 10% Inj
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns
Class II · Moderate risk Terminated
Benzalkonium Chloride 0.013% Solution
Reason Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns