FDA WARNING_LETTER - Adamis Pharmaceuticals

This Warning Letter, dated June 9, 2010, was issued to Adamis Pharmaceuticals concerning their marketing of Epinephrine Injection 1:1000 (0.3 mg prefilled single dose syringe). The FDA determined that this product is an unapproved new drug, violating sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act, as no FDA-approved application is on file. Additionally, the product is misbranded under section 502(f)(1) of the Act because its labeling lacks adequate directions for use, as it is intended for conditions not amenable to self-diagnosis and treatment by laypersons, and it is not exempt under 21 C.F.R. § 201.115. The introduction of this product into interstate commerce also violates section 301(a) of the Act. Adamis Pharmaceuticals is required to promptly correct these violations, investigate their causes, and prevent recurrence. The firm must notify the FDA within fifteen working days with a plan to cease violative activities, dispose of current inventory, address distributed product, and update Drug Listing files if marketing ceases. Failure to comply may result in legal action, including seizure and injunction, and may impact federal contracts.