All Recalls

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.

Lack of Processing Controls

Subpotent Drug

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Subpotent Drug

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Lack of Processing Controls

Stability Data Does Not Support Expiry

Failed Content Uniformity Specifications.

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with undeclared sibutramine, an appetite suppressant that was withdrawn from the US market for safety reasons, making it an unapproved drug.

Lack of Processing Controls

Lack of Processing Controls

Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vial on all containers.

Lack of Processing Controls

Subpotent Drug

Lack of Processing Controls