Upon request of the FDA, Hardmenstore.com is voluntarily recalling 1000 lots of 72HP, Evil Root and Pro Power Max at the consumer level. According to representatives of the FDA, 72HP, Evil Root and Pro Power Max have reportedly been found to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED).
If there is microbial contamination in medications intended to be sterile, patients are at risk of serious infections which may be life threatening.
If there is microbial contamination in products intended to be sterile, patients are at risk for serious, potentially life-threatening infections.
This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used by Front Range Labs to assess sterility and other qualities (e.g., strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots.
WICHITA, Kan. – JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by the U.S. Food and Drug Administration of Front Range Laboratories of Loveland, Colo., one of the contract testing labs used by JCB. The following compounded products are subject to the recall:
Methods used by the laboratory to assess sterility may have resulted in pharmacies receiving inaccurate laboratory test results.