Class II · Moderate risk Terminated
Isosorbide Dinitrate Tablets
Reason Cross Contamination with Other Products
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Isosorbide Dinitrate Tablets
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Nitrofurantoin Capsules
Reason Cross Contamination with Other Products
Class III · Low risk Terminated
Curaplex Epi Safe Kit
Reason Labeling: Incorrect or missing Lot and/or Exp Date:The Kit is incorrectly labeled as expiring May 2018 however the correct expiration date is May 2019. In addition, device component (syringe) lacks 510(k) clearance.
Class II · Moderate risk Terminated
curaplex Epi Safe Administration and Training Kits # 8600-01100…
Reason Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition, device component (syringe) may lack 510(k) clearance.
Class II · Moderate risk Ongoing
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets
Reason CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Class II · Moderate risk Terminated
Bevacizumab 2.5 Mg/0.1ml
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Clindamycin Phosphate Topical Solution USP
Reason Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class II · Moderate risk Terminated
Omnipaque
Reason Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
Westminster Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
GSMS Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminister Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminister Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk Terminated
Westminister Irbesartan Tablets
Reason CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class I · High risk Terminated
Levetiracetam in 0.54 % Sodium Chloride Injection 1
Reason Labeling: Label Error on Declared Strength; the pre-printed text on the primary infusion bag and the NDC incorrectly identifies the product as Levetiracetam in 0.75% Sodium Chloride (1000 mg/100 mL) however, the external foil pouch correctly identifies the product as Levetiracetam in 0.54% Sodium Chloride Injection (1,500/100 mL).
Class III · Low risk Terminated
Metoprolol Tartrate Injection
Reason Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class II · Moderate risk Terminated
Alcohol Free Foaming Hand Sanitizer
Reason CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk Terminated
deb stoko
Reason CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk Terminated
Irbesartan Bulk Active Pharmaceutical Ingredient.
Reason CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk Terminated
Ortho-Novum 7/7/7
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk Terminated
Ortho-Novum 1/35
Reason Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.