Drugs Recalls

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Lack of Assurance of Sterility

Failed Impurities/Degradation Specifications

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Lack of Assurance of Sterility

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.

Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.