These injectable products are being recalled because they were marketed without FDA approval. The statement adds: “The products claims on our website make these products unapproved new drugs. Further, the products are misbranded because the labeling fails to bear adequate directions for use.”
The statement contains the following warning: “Unapproved new drugs injected into the bloodstream for which safety and efficacy have not been established could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis.”
Biota Biosciences has not received any reports of adverse events related to the recall.
Products were distributed nationwide in the U.S. and to one consignee in New Zealand.