FDA WARNING_LETTER - klasiekpharmacy.com - September 10, 2020

The FDA issued a Warning Letter to www.klasiekpharmacy.com for offering misbranded and unapproved new opioid drugs for sale to U.S. consumers, violating sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act. The agency highlighted the severe public health crisis of opioid addiction and abuse, emphasizing the significant risks posed by easily accessible, unregulated opioids online. Specifically, products like "TRAMADOL-X 225" are considered unapproved new drugs because no FDA-approved applications are in effect, lacking assurance of safety and effectiveness. Furthermore, these drugs are misbranded under section 502(f)(1) of the FD&C Act as they fail to bear adequate directions for use by a layperson, particularly as prescription drugs requiring professional supervision. The FDA noted that unapproved drugs may be contaminated, counterfeit, or contain incorrect active ingredients, and cited the serious risks associated with tramadol, including addiction and life-threatening respiratory depression. The company is required to immediately cease offering violative drugs and notify the FDA within 15 working days of corrective actions taken to prevent recurrence, or face potential regulatory actions like seizure or injunction.