Class III · Low risk Ongoing
Estradiol Transdermal System
Reason Failed Impurities/Degradation Specifications.
FDA Drug Recalls
2,661 recalls, newest first
Class III · Low risk Ongoing
Pregabalin Capsules 50mg
Reason Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pantoprazole tablet 20mg.
Class II · Moderate risk Ongoing
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Klarity-C
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin- Ketorolac
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Dexamethasone-Moxifloxacin
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Orally Disintegrating Tablets
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g
Class III · Low risk Ongoing
Cephalexin for Oral Suspension
Reason Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets USP
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Rizatriptan Benzoate Tablets USP
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Cap USP 30mg
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk Ongoing
Drug Vial Label: Zilretta¿
Reason Failed Stability Specifications - at 12 months 2-8 degrees C followed by 6 weeks at 25 degrees C.
Class II · Moderate risk Ongoing
Losartan Potassium and Hydrochlorothiazide Tablets
Reason Presence of foreign substance: plastic-like substance.
Class II · Moderate risk Ongoing
Metoprolol Tartrate Tablets USP
Reason Presence of Foreign Substance: metal in tablet
Class III · Low risk Ongoing
Sirolimus Tablets 1mg Tablets 100-count bottle
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
Meijer Magnesium Citrate Saline Laxative Oral Solution Dye Free
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria