Class II · Moderate risk Ongoing
Suave Inv Sld Pwdr 1.2 Oz Sku2004504 Suave Ap Inv Solid Sweet…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Ongoing
Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
Colgate Max Fresh Clean Mint 1.9oz Sku 900596 Colgate Cavity…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
Banana Boat Sprt Clr Spry Spf50 6 Fl Oz Sku 2007524 Suntone…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Terminated
Testosterone Cypionate Injection
Reason cGMP - Water leakage
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules
Reason Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Class I · High risk Terminated
Morphine Sulfate extended-Release Tablets
Reason Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk Terminated
Morphine Sulfate extended-Release Tablets
Reason Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class II · Moderate risk Terminated
Draximage MAA
Reason Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.
Class II · Moderate risk Terminated
Eszopiclone Tablets
Reason Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class III · Low risk Terminated
Mometasone Furoate
Reason Defective Container
Class II · Moderate risk Terminated
70% ISOPROPYL ALCOHOL First aid antiseptic
Reason Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
Class II · Moderate risk Terminated
Tretinoin Capsules
Reason Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class I · High risk Terminated
CVS Health Magnesium Citrate SALINE LAXATIVE
Reason Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class II · Moderate risk Terminated
Fluticasone Propionate Nasal Spray
Reason Defective container: defect prevents product from dispensing as intended.
Class I · High risk Terminated
Arti King Refozado con Ortiga y Omega 3 Tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Estriol 1mg/gm
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Boric Acid 600 mg per suppository
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Class II · Moderate risk Terminated
Boric Acid 600 mg capsules
Reason Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection