Paddock Laboratories, Inc. – FDA Warning Letter

The FDA issued a Warning Letter to Paddock Laboratories, Inc. on March 1, 2010, regarding their unapproved new drug, Morphine Sulfate Concentrate Oral Solution 20 mg/ml. The product is deemed a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its labeled uses.

The primary violation is the marketing of this drug without an FDA-approved application, which contravenes sections 301(d) and 505(a) of the Federal Food, Drug, and Cosmetic Act (the Act). Additionally, the product is misbranded under section 502(f)(1) of the Act because it lacks adequate directions for use by a layman, as it's intended for conditions requiring medical practitioners.

The FDA will exercise enforcement discretion and not initiate action related to this product manufactured as of the letter's date, provided manufacturing and/or shipment ceases by July 24, 2010. This discretion will not apply if other Act violations occur, if manufacturing/shipment volume increases, or if new serious health risks are identified. Paddock Laboratories must respond within fifteen working days, detailing their plan to cease violative activities. Failure to correct these violations may result in legal action, including seizure and injunction.