Class II · Moderate risk
Latanoprost 0.025% eye drop
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
FDA Drug Recalls
18,003 recalls, newest first
Class II · Moderate risk
Laser ophthalmic drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Itraconazole 1% eye ointment
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Injection vehicle
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Hydroxyprogesterone 250 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
HCG 500 units/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
HCG 2000 units/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
HCG 1000 units/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Gentamicin buffered 36.4 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Valerate 30 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Valerate 20 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk
Estradiol Cypionate 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Diazepam 5 mg/ml
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cyclosporine 2% ophthalmic
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cyclosporine 1% ophthalmic drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Cataract drops
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 2 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 20 % solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Acetylcysteine 10 % Solution
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class III · Low risk
Disulfiram Tablets USP 250 mg
CGMP Deviation; cotton coil is missing in some packaged bottles
Class III · Low risk
Tizanidine Tablets USP
Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.
Class I · High risk
Piperacillin and Tazobactam for Injection
Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.
Class III · Low risk
Camila 0.35 mg Tablets
Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Class III · Low risk
Oxcarbazepine Tablets
SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.
Class III · Low risk
Cherry Cepacol Sore Throat Lozenges
Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.