Prescription Drugs

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Sub-potent drug: failure to maintain potency through the duration of the labeled expiration/beyond-use date.

an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Misprint on tablet

CGMP Deviations

Misprint on tablet

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

CGMP Deviations: Inadequate induction sealing on bottles, capsules were observed with bubbles on band seal, capsules with holes and spheres sticking to capsules. Also coding details were missing on one bottle.

Failed Impurities/Degradation Specifications: Out of Specification (OOS) result in the repackaged product for Related Compounds (Impurities) at the 6-month time point.

Failed Dissolution Specifications

Failed Dissolution Specifications

Labeling: Label Mix-up

CGMP Deviations: products may not conform to the labeled specifications.

Subpotent Drug and Failed Impurities/Degradation Specifications

Failed Impurities/Degradation Specification.

Failed Impurities/Degradation Specifications

Subpotent Drug and Failed Impurities/Degradation Specifications