Drugs Recalls

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Presence of Particulate Matter: Confirmed customer compliants of finding an insect floating in the primary container of each product.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.

Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Labeling: Not Elsewhere Classified: Potassium Chloride was printed on Potassium Phosphate label stock thereby having both names on the label of a 250 mL bag of Potassium Chloride.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Failed Impurity/Degradation Specifications: Out of specifications for unknown impurity.

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products were found to be tainted with undeclared hydroxythiohomosildenafil, an analogue of Sildenafil, an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making them unapproved new drugs.

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.