AmCon Initiates Immediate Recall of Busimax®

AmCon Initiates Immediate Recall of Busimax®

FOR IMMEDIATE RELEASE – May 1, 2015 – AmCon, LLC today announced that it is conducting a nationwide recall to the hospital/user level of all lots of Busimax® Capsules due to unforeseen interactions with a number of classes of common over-the-counter medications, including generic calcium supplements, birth-control regimens, Acetaminophen, Guaifenesin, Phenylephrine, and Diphenhydramine, as well as unexpected side effects when taken conta-indication, e.g. by the pre-pubescent or those still in the main stages of pubescent growth. All retailers, distributors, and customers are encouraged to immediately cease all Busimax® regimens and discard unused product at the place of purchase.

Interaction Details

Busimax® was intended to treat lack of secondary pubescent characteristics in post-pubescent women with a once-a-day tablet. Soon after release to the market, reports were received of unexpected interactions when common medications were consumed alongside Busimax®, or Busimax® was taken by those other than it was specifically prescribed for, or against the indicated method. A small sampling of cases, so that abuse or side effects can be identified by professionals in local communities:

• The teenaged daughter of a patient prescribed Busimax® began consuming the tablets. Recorded a growth spurt of over two feet in three weeks, with secondary sexual characteristics also growing rapidly. The girl is currently over seven feet tall, and her height is still increasing, although the rate is leveling off.
• A patient who came down with the common flu began taking Acetaminophen alongside her Busimax® tablets. Anomalous breast growth was reported soon afterward. Patient currently cannot reach nipples, but refuses cosmetic surgery.
• One patient initiated a sexual relationship with a new male partner during her Busimax® treatment. Anomalous penile growth and stamina has been recorded, with the partner’s erection now measuring over 400 mm. Patient reports no pain during lengthy intercourse.
• AmCon has also received reports of pregnancy interacting with Busimax®. In one case, a patient started a high-dosage Busimax® regimen while unknowingly also one month pregnant. Two months later, she gave birth to fraternal female twins of a healthy size and weight, who have displayed their own anomalous growth patterns, including early language development and precocious puberty.

For these and other reasons, AmCon LLC is initiating this recall.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.