Class III · Low risk
Trokendi XR
Failed dissolution specifications.
FDA Drug Recalls
43 recalls · Class III, newest first
Class III · Low risk
Olanzapine Tablets
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class III · Low risk
Fluphenazine Hydrochloride Tablets
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Class III · Low risk
Class III · Low risk
Buprenorphine Sublingual Tablets
Labeling: Label Mix-up
Class III · Low risk
Revcovi (elapegademase-lvlr)
Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
Class III · Low risk
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg
Presence of Foreign Tablets/Capsules
Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class III · Low risk
Trokendi XR
Failed Dissolution Specifications
Class III · Low risk
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Class III · Low risk
Dabigatran etexilate Capsules
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Class III · Low risk
Primidone Tablets
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Focalin XR
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Lidocaine HCl Injection
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class III · Low risk
Epinephrine Injection
Failed Impurities/Degradations Specifications
Class III · Low risk
Nicotine Transdermal System Patch
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units.
Class III · Low risk
Busulfan Injection
Failed Impurities/Degradation Specifications
Class III · Low risk
Primidone Tablets
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.