Unapproved and Misbranded Oral and Injectable Drugs Labeled for Prescription Use Containing Codeine Sulfate, Codeine Phosphate, or Dihydrocodeine Bitartrate; Enforcement Action Dates

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The Food and Drug Administration (FDA or the Agency) is announcing its intention to take enforcement action against unapproved and misbranded oral and injectable drug products labeled for prescription use and containing codeine sulfate, codeine phosphate, or dihydrocodeine bitartrate, and against persons who manufacture or cause the manufacture or distribution of such products in interstate commerce. Prescription drug products containing these ingredients pose serious risks, including the risk of addiction, and some unapproved drug products may lack warnings or other information required in the labeling of approved drug products that is important for safe use. These unapproved drug products compete with approved drug products and thus pose a direct challenge to the drug approval system. This document covers the following unapproved drug products labeled for prescription use: Single-ingredient codeine sulfate oral tablets and solutions, single-ingredient codeine phosphate injection products, fixed-dose combination products containing codeine phosphate, and fixed-dose combination products containing dihydrocodeine bitartrate. A new drug containing codeine sulfate, codeine phosphate,