Class II · Moderate risk
Isosorbide Dinitrate Tablets
Cross Contamination with Other Products
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Isosorbide Dinitrate Tablets
Cross Contamination with Other Products
Class III · Low risk
Nitrofurantoin Capsules
Cross Contamination with Other Products
Class III · Low risk
Curaplex Epi Safe Kit
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
curaplex Epi Safe Administration and Training Kits # 8600-01100…
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
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets
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
Bevacizumab 2.5 Mg/0.1ml
Lack of Assurance of Sterility
Class III · Low risk
Clindamycin Phosphate Topical Solution USP
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
Class II · Moderate risk
Omnipaque (iohexol)
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
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk
Westminster Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
GSMS Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class II · Moderate risk
Westminister Irbesartan Tablets
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Class I · High risk
Levetiracetam in 0.54 % Sodium Chloride Injection 1
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
Metoprolol Tartrate Injection
Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
Class II · Moderate risk
Alcohol Free Foaming Hand Sanitizer
CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk
deb stoko
CGMP Deviations: Product was released to market prior to microbiological testing.
Class II · Moderate risk
Irbesartan Bulk Active Pharmaceutical Ingredient.
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class II · Moderate risk
Ortho-Novum 7/7/7
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.
Class II · Moderate risk
Ortho-Novum 1/35
Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.