Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.
Class III · Low risk Terminated
Acne Treatment Pads
Reason Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class III · Low risk Terminated
Cicatricure
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Class III · Low risk Terminated
Well at Walgreens
Reason Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.
Class III · Low risk Terminated
Atorvastatin Calcium tablets
Reason Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Levofloxacin Injection in 5% Dextrose
Reason Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.
Class III · Low risk Terminated
Testosterone 200 mg Pellet
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Incorrect expiration date on label
Class III · Low risk Terminated
Fluconazole Injection
Reason Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Class III · Low risk Terminated
Fluconazole Injection
Reason Failed Stability Specifications: lot out of specification for elevated water vapor.
Class III · Low risk Terminated
Fluconazole Injection
Reason Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
Class III · Low risk Terminated
Diazepam Rectal Gel
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class III · Low risk Terminated
Triamterene and Hydrochlorothiazide Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Enalapril Maleate
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk Terminated
Enalapril Maleate
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk Terminated
Enalapril Maleate
Reason Out-of-specification results for the Enalapril Diketopiperazine degradation product during commercial stability.
Class III · Low risk Terminated
Enalapril Maleate Tablets
Reason Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk Terminated
Enalapril Maleate Tablets
Reason Failed Impurities/Degradation Specifications: Sub-recall because this repackaged product was recalled by the manufacturing firm, Wockhardt, due to out-of-specification results for the Enalapril DiKetopiperazine degradation product.
Class III · Low risk Terminated
Enalapril Maleate Tablets USP
Reason Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT degradant
Class III · Low risk Terminated
Enalapril Maleate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Enalapril Maleate Tablets USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Rocaltrol
Reason Subpotency: lower than expected potency result was obtained at the 18 month stability time point.