Class I · High risk Terminated
Chlorhexidine Gluconate 0012 For Manufacturing
Reason Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia marcescens in certain API batches
FDA Drug Recalls
14,801 recalls, newest first
Class I · High risk Terminated
All Clean Hand Sanitizer
Reason Chemical Contamination: Product contains undeclared methanol.
Class I · High risk Terminated
ChlroraPrep One-Step
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk Terminated
ChloraPrep With Tint
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk Terminated
BD ChloraPrep Clear 3 mL Applicators
Reason Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class III · Low risk Terminated
Tecfidera
Reason cGMP deviations: one lot of the product was distributed to US Markets despite being rejected during in-process control.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class III · Low risk Terminated
Nystatin Oral Suspension
Reason Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Class I · High risk Terminated
Saniderm ADVANCED HAND SANITIZER
Reason Chemical Contamination: Product contains undeclared methanol.
Class III · Low risk Terminated
Famotidine Injection
Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Class II · Moderate risk Terminated
Metformin HCl Extended Release Tablets
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Class II · Moderate risk Terminated
Childrens Dimetapp Cold & Cough
Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk Terminated
Childrens Robitussin Honey Cough and Chest Congestion DM
Reason Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
Class II · Moderate risk Terminated
Heparin Sodium 5
Reason Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Class II · Moderate risk Terminated
Tropical Lip Moisturizer
Reason Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Class II · Moderate risk Terminated
Clozapine Tablets USP tablet
Reason Presence of foreign tablet: Consumer complaint of Clozapine Tablets 50mg being present in 500 count bottles of Clozapine Tablets USP 100mg.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Class II · Moderate risk Terminated
Koala Hand Sanitizer
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk Terminated
Koala Hand Sanitizer
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk Terminated
Koala Hand Sanitizer
Reason Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended-release Tablets USP
Reason CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Irinotecan HCL Injection
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class II · Moderate risk Terminated
Irinotecan HCL Injection
Reason Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Class III · Low risk Terminated
Nabumetone Tablets
Reason Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label.
Class II · Moderate risk Terminated
Aripiprazole Tablets
Reason Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tablets, 100 count.