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In March of 2001, the FDA, based on contact made with major manufacturers of Naloxone Hydrochloride Injection, USP, and several large pharmaceutical distributors, confirmed reports of a nationwide shortage of this product. Significant facility renovations and lack of inventory build-up appear to have caused this shortage. From discussions with all parties, this shortage appears to be a temporary situation of two to three months in length.

In response to the shortage of this medically necessary product, FDA has identified a temporary alternate supplier of Naloxone Hydrochloride Injection, USP. Sabex, Inc. Boucherville, Quebec, Canada, has been granted the ability to temporarily supply Naloxone Hydrochloride to the United States in 0.4 mg/mL ampoules (1mL) and vials (10mL), as well as 1 mg/mL vials (2mL) effective April 4, 2001. This product will be labeled as manufactured by Sabex, Inc. and sold only by telephone and Fax orders placed at their headquarters in Canada. Physicians and hospitals will be able to obtain this product via overnight delivery, as Sabex® has been granted the authority to warehouse product in the United States. Limited supplies will be available and Sabex® will be operating under a drug shortage allocation program.

The Sabex® product is preserved with both methyl (0.18%) and propyl (0.2%) parabens and is not intended for intrathecal use.

This temporary program will not cover the pediatric strength of product (0.02 mg/mL) and the Agency cautions all physicians and hospital to conserve its use whenever possible, until U.S. manufacturers can increase their production of this strength. Supplies of this strength are available, but limited. FDA has been in contact with all U.S. manufacturers and urged them to make this strength their first priority in production. The Agency continues to monitor this situation.

To order Naloxone Hydrochloride during this temporary period, contact the Sabex order desk via:

Toll-free phone 1-800-361-3062
FAX 1-800-343-8830

FDA will continue to monitor this important health issue until its resolution. Updates will be posted on the FDA Drug Shortage Website located at www.fda.gov/cder/drug/shortages.

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