FDA WARNING_LETTER - Akorn, Inc. - October 02, 2012

This FDA Warning Letter, dated October 2, 2012, was issued to Akorn, Inc. for manufacturing unapproved new drugs. The firm manufactures Pilocarpine Hydrochloride Ophthalmic Solution, USP 1%, 2%, and 4%. These products are classified as "new drugs" under Section 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are not generally recognized as safe and effective for their labeled uses.

The primary violation is the introduction or delivery of these new drugs into interstate commerce without FDA-approved applications, which violates Sections 301(d) and 505(a) of the Act. Additionally, as prescription drugs, their labeling fails to bear adequate directions for use, making them misbranded under Section 502(f)(1) of the Act, a violation of Section 301(a).

FDA stated it would not initiate enforcement action for manufacturing these products for 90 days, or for shipping them for 180 days, provided Akorn does not violate other provisions, increase production, or if new health risks emerge. Akorn must investigate and correct these violations promptly. Within 15 working days, Akorn must notify FDA in writing of its plan to cease violative activities, including whether manufacturing has stopped, the reasons and date, details of other manufacturers/suppliers, and progress in updating FDA's Drug Registration