Class II · Moderate risk
Hydroxycobalamine 30 mg/mL
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Folic Acid
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Folic Acid
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Estradiol cypionate/Test cyprionate
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
calcium elemental
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Bupivacaine
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Lyrica (pregabalin)
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class II · Moderate risk
Lyrica (pregabalin)
FAILED TABLET/CAPSULE SPECIFICATIONS: Firm is recalling specific lots of pregabalin capsules due to the potential presence of deformed or damaged capsules.
Class II · Moderate risk
Guaifenesin DM Cherry liquid
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class II · Moderate risk
Guaifenesin Grape liquid 100 mg/5 mL
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class II · Moderate risk
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness test
Class II · Moderate risk
Baclofen
Lack of assurance of sterility
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class II · Moderate risk
IT Custom Compound
Lack of Assurance of Sterility
Class II · Moderate risk
Baclofen 1 mg/ml in 40 ml NS syringe
Lack of Assurance of Sterility
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Energique
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Daytrana (methylphenidate transdermal system)
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Class II · Moderate risk
Capecitabine tablets USP 500 mg
Failed Dissolution Specifications: low test results at the 18 month time-point