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On December 11, 2006, the Food and Drug Administration issued an order* to cease U.S. manufacturing of unapproved products containing quinine, including quinine sulfate and any other salt of quinine on or after February 13, 2007, and to cease shipping such products interstate on or after June 13, 2007. After these dates only FDA-approved quinine products may be manufactured and shipped interstate. However, there may continue to be some of these quinine products on pharmacy shelves until the expiration dates of these products are reached.
This action does not affect quinine drug products marketed with FDA approval. FDA has approved one quinine drug product* for the treatment of malaria, which is manufactured by Mutual Pharmaceutical Company, Inc. (Mutual), of Philadelphia, PA.
It contains quinine sulfate as the active ingredient without any additional active ingredients in 324 mg capsules and is sold under the trade name Qualaquin (quinine sulfate) with the following NDC number: 13310-153-07. At this time, there is no evidence of any shortages or limited availability of quinine. If a pharmacy has difficulty obtaining Qualaquin, they may contact Mutual at 215-697-1900.
Additional details can be found on the FDA website at:
 http://www.fda.gov/cder/drug/unapproved_drugs/quinineQA.pdf.* (30 KB/5 pages)
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Page last modified : January 8, 2006
Content source: Division of Parasitic Diseases
National Center for Zoonotic, Vector-Borne, and Enteric Diseases (ZVED)
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