Notify FDA of Illegitimate Products Manufacturers, repackagers, wholesale distributors, and dispensers are required to notify FDA within 24-hours after determining a product is illegitimate. Sign up […]

Prescription drugs should only be purchased from wholesale drug distributors holding a valid license in the United States and who are authorized1  by law. Unlicensed and […]

Delivery Method: VIA Electronic Mail Product: Drugs Issuing Office: Division of Human and Animal Food Operations East IV United States WARNING LETTER 24-HAFE4-WL-01 / CMS No. […]

Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 24-HFD-45-04-01 Product: Drugs Recipient: Recipient Name Kevin R. Bender, M.D. Kevin R. Bender, M.D./DBC Research […]

Delivery Method: VIA UPS Product: Drugs Recipient: Recipient Name Ms. Ranki Liu Recipient Title Product Technical Manager Global Cosmetics Company Limited No. 13 Gaobao Road, Changping […]

Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Mr. Norikazu Toyoda Recipient Title President and CEO Kobayashi Healthcare International, Inc. 245 Kraft Dr.Dalton, GA […]

Acetaminophen-containing products Metabolic acidosis FDA is evaluating the need for regulatory action. Certain adenosine injection (generic product) Certain amiodarone hydrochloride injection (generic product) Look alike container […]

Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. Certain product lots were associated with increased reports of false negative […]

Export Regulations and Guidance Documents The Federal Food Drug and Cosmetics Act and Code of Federal Regulations (CFR) requirements are applicable to human drug exports for […]