FDA WARNING_LETTER - Bulk2USA

The FDA issued a Warning Letter to Bulk2USA for offering unapproved new drugs and misbranded drugs for sale on multiple websites, including buyrx-online.com and medscareonline.com. The review determined these products violate sections 301(a), 301(d), 301(k), 503(b), and 505(a) of the FD&C Act.

Violations include selling unapproved new drugs like hydrocodone and acetaminophen 10/500 mg and "Tramal SR" (tramadol). The hydrocodone product contains 500 mg of acetaminophen, exceeding the FDA's 325 mg limit due to liver injury risk, and both lack FDA approval and required boxed warnings for risks like addiction and respiratory depression.

Additionally, the websites offer prescription drugs (e.g., opioids like tramadol and hydrocodone) without requiring a prescription, which misbrands them under section 503(b)(1) and 301(k) of the FD&C Act. These drugs also lack adequate directions for layperson use, violating section 502(f)(1).

The FDA emphasizes the inherent risk to consumers from unapproved and misbranded drugs, which may be contaminated, counterfeit, or have incorrect active ingredients. Bulk2USA must immediately cease marketing violative drug products and notify the FDA within 10 working days of