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MEETINGS / EVENTS

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January 23 - 25 2015, 12:00 AM - 12:00 AM

ASA PRACTICE MANAGEMENT 2015

February 07 - 08 2015, 12:00 AM - 12:00 AM

ASA Certificate in Business Administration 2015

June 26 - 28 2015, 12:00 AM - 12:00 AM

Annual Perioperative Surgical Home Summit

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FDA MEDWATCH ALERTS

November 21, 2014

FDA MedWatch - Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur

Summary:

FDA MedWatch Respironics California Esprit V1000 and V200 Ventilators Class I Recall

November 07, 2014

FDA MedWatch - Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator

Summary:

FDA MedWatch Nellcor Puritan Bennett 980 Ventilator System Class I Recall

October 25, 2014

FDA MedWatch - Intravia Containers by Baxter: Recall - Particulate Matter

Summary:

FDA MedWatch Intravia Containers by Baxter Recall

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FDA Removes Unapproved Prescription Drug Products Containing Codeine and Dihydrocodeine from the Market

Monday, January 13, 2014

The U.S. Food and Drug Administration (FDA) has ordered companies to stop manufacturing and distributing unapproved prescription drug products containing codeine and unapproved prescription drug products containing dihydrocodeine as of February 24, 2014 and April 10, 2014, respectively. 

The drugs covered by this action lack the required FDA approval and are:

  • single-ingredient codeine sulfate oral tablets;
  • single-ingredient codeine phosphate injections;
  • combination products containing codeine phosphate; and
  • combination products containing dihydrocodeine bitartrate.  

For historical reasons, some prescription drug products are available in the United States but lack FDA approval for marketing.  FDA is taking this action as part of the Agency’s continuing effort to ensure that prescription drugs marketed in the United States  have the required FDA approval, which means that they have been found to be safe, effective, of good quality, and are appropriately labeled. 

According to the FDA, the announced removal  is not a recall, and previously manufactured unapproved drug products affected by this action may still be found on pharmacy shelves for a short period of time (until the inventory has been depleted or until the products’ expiration date).

Read FDA’s Q&A on the removal of these products from the market.

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