Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Oxybutynin Chloride
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Lovastatin Tablets USP
Reason CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class III · Low risk Terminated
Temozolomide Capsules
Reason Failed dissolution specifications
Class III · Low risk Terminated
Lovastatin Tablets USP
Reason CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.
Class III · Low risk Terminated
Ciclopirox shampoo 1%
Reason Failed Degradation/Impurities Specifications: Out of specification related substance results during stability testing.
Class III · Low risk Terminated
Diltiazem HCl Extended-Release Capsules
Reason Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing
Class III · Low risk Terminated
Mometasone Furoate Cream
Reason Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.
Class III · Low risk Terminated
Esomeprazole Magnesium Delayed-Release Capsules USP
Reason Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.
Class III · Low risk Terminated
Oxytocin 30 Units added to NS 500 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Oxytocin 20 Units added to NS 1000 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Oxytocin 10 Units added to NS 1000 mL
Reason Superpotent Drug: product may contain concentrations of oxytocin higher than what is represented on the label.
Class III · Low risk Terminated
Moxifloxacin Ophthalmic Solution USP
Reason Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.
Class III · Low risk Terminated
Diltiazem HCl CD capsules
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk Terminated
Cardizem CD
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk Terminated
Cardizem CD
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk Terminated
Cardizem CD
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk Terminated
Cardizem CD
Reason Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Class III · Low risk Terminated
Bimatoprost Ophthalmic Solution 0.03%
Reason Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Class III · Low risk Terminated
Clobetasol Propionate Emollient Cream 0.05%
Reason Failed Stability Specification; out of specification (OOS) results for a preservative at 9 month stability study.
Class III · Low risk Terminated
Clobetasol Propionate Topical Solution USP
Reason Defective Container; complaints of leakage.
Class III · Low risk Terminated
Loperamide HCL Tablets USP
Reason Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Class III · Low risk Terminated
COSOPT Ophthalmic Solution
Reason Failed Stability Specifications: out of specification results for opalescence at 7 month stability study.
Class III · Low risk Terminated
Temozolomide Capsules
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Temozolomide Capsules
Reason Failed Dissolution Specifications