Bulletin
Haloperidol Decanoate Injection
29 October 2009
Products Affected - Description
Haloperidol decanoate injection, Bedford
100 mg/mL, 5 mL vial (NDC 55390-0413-05)
50 mg/mL, 5 mL vial (NDC 55390-0412-05)
Haloperidol decanoate injection, APP
50 mg/mL, 1 mL vial (NDC 63323-0469-01)
100 mg/mL, 1 mL vial (NDC 63323-0471-01)
Haloperidol decanoate injection, Apotex
100 mg/mL, 5 mL vial (NDC 60505-0703-01)
50 mg/mL, 5 mL Novaplus vial (NDC 60505-6020-02)
Reason for the Shortage
Bedford, APP, Teva, and Apotex could not provide a reason for the shortage.
Estimated Resupply Dates
- Bedford has haloperidol decanoate available in 50 mg/mL 1 mL vials (NDC 55390-0412-01) and 100 mg/mL 1 mL vials (NDC 55390-0413-01). The 50 mg/mL 5 mL vials and 100 mg/mL 5 mL vials on back order and the company cannot estimate a release date.
- APP has haloperidol decanoate available in 50 mg/mL 5 mL vials (NDC 63323-0469-05) and 100 mg/mL 5 mL vials (NDC 63323-0471-05). The 50 mg/mL 5 mL vials (NDC 63323-0469-05) are available with an expiration date of February, 2010. The 50 mg/mL 1 mL vials are on back order and the company estimates a release date of early-November, 2009. The 100 mg/mL 1 mL vials are on back order and the company cannot estimate a release date.
- Teva has haloperidol decanoate available in 50 mg/mL 1 mL (NDC 00703-7011-03), 50 mg/mL 5 mL (NDC 00703-7013-01), 100 mg/mL 1 mL (NDC 00703-7021-03), and 100 mg/mL 5 mL (NDC 00703-7023-01) vials.
- Ortho-McNeil has Haldol decanoate available in 50 mg/mL 1 mL ampules (NDC 00045-0253-03) and 100 mg/mL 1 mL ampules (NDC 00045-0254-14).
- Apotex has haloperidol decanoate available as 50 mg/mL 5 mL vials (NDC 60505-0702-01). The 100 mg/mL 5 mL Novaplus vials (NDC 60505-6021-02) are available with an expiration date of February, 2010. Limited quantities of the Novaplus 50 mg/mL 5 mL vials (NDC 60505-6020-02) are available and the company cannot estimate when additional stock will be available. The 100 mg/mL 5 mL vials (NDC 60505-0703-01) are on back order and the company cannot estimate a release date.
Related Shortages
Updated
October 29, 2009; October 8, 2009; September 21, 2009; August 26, 2009; August 3, 2009; June 30, 2009; June 16, 2009; June 1, 2009; May 12, 2009; April 1, 2009, University of Utah, Drug Information Service. Copyright 2009, University of Utah, Drug Information Service.
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