Prescription Drugs

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

Failed Dissolution Specification; 8 hr stability timepoint

Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

Marketed Without an Approved NDA/ANDA; product found to contain Doxepin (an antidepressant) and Chlorpromazine (an antipsychotic)

Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

Failed Dissolution Specifications; 12 month acid dissolution test results were above upper limit specifications.

Marketed Without An Approved NDA/ANDA: FDA analysis found eXtenZone which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved b

Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

Presence of Particulate Matter: Failed the appearance test for the presence of visible particles.

Failed Tablet/Capsule Specifications; Product contains broken tablets.

Marketed Without an Approved NDA/ANDA; this product is being recalled for containing an undeclared diuretic called Triamterene, an FDA approved prescription only medication used to treat edema, making it an unapproved new drug

Lack of Assurance of Sterility; potential leakage from administrative port.

Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved

Lack of Assurance of Sterility; potential leakage from administrative port.

Marketed Without An Approved NDA/ANDA: FDA analysis found Rhino 5 which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved by

Labeling: Label Mixup: FLUCONAZOLE, Tablet, 200 mg may have potentially been mislabeled as one of the following drugs: VALSARTAN, Tablet, 80 mg, NDC 00078035834, Pedigree: AD65475_10, EXP: 5/28/2014; FLUCONAZOLE, Tablet, 100 mg, NDC 68462010230, Pedigree: W003064, EXP: 6/12/2014.

Labeling: Label Mixup: PERPHENAZINE, Tablet, 8 mg may have potentially been mislabeled as the following drug: NIFEdipine, Capsule, 10 mg, NDC 59762100401, Pedigree: AD52778_55, EXP: 5/20/2014.

Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.

Labeling: Label Mixup: SILDENAFIL CITRATE, Tablet, 25 mg may have potentially been mislabeled as the following drug: PHENobarbital/ HYOSCYAMINE/ ATROPINE/ SCOPOLAMINE, Tablet, 16.2 mg/0.1037 mg/0.0194 mg/0.0065 mg, NDC 66213042510, Pedigree: W003640, EXP: 6/25/2014.