Class II · Moderate risk Terminated
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
FDA Drug Recalls
17,898 recalls, newest first
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 II · Moderate risk Terminated
Vasopressin Injection
Reason Subpotent product in addition to having out-of-specification results for impurities.
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 Terminated
Cefdinir for Oral Suspension USP
Reason Defective container: lack of seal integrity.
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 II · Moderate risk Terminated
TraMADol HCl 50 mg Tablet
Reason Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
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
Class II · Moderate risk Ongoing
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE…
Reason Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Class II · Moderate risk Completed
Cardura XL
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Completed
Cardura XL
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Completed
Fentanyl 1000mcg/100mL
Reason Labeling: Wrong Barcode
Class I · High risk Completed
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free
Reason Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit