Bulletin
Belladonna Alkaloids with Phenobarbital
15 October 2009
Products Affected - Description
Belladonna with Phenobarbital Elixir
Donnatal elixir, 120 mL (NDC 66213-0423-04), PBM Pharmaceuticals
Donnatal elixir, 473 mL (NDC 66213-0423-16), PBM Pharmaceuticals
Belladonna/phenobarbital elixir, 480 mL (NDC 00603-1030-58), Qualitest - discontinued
Belladonna/phenobarbital elixir, 480 mL (NDC 00254-9035-58), Vintage - discontinued
Belladonna with Phenobarbital Tablets
Belladonna/phenobarbital tablets, 100 count (NDC 00603-2418-21), Qualitest - discontinued
Belladonna/phenobarbital tablets, 1000 count (NDC 00603-2418-32), Qualitest - discontinued
Belladonna/phenobarbital tablets, 100 count (NDC 00254-2320-28), Vintage - discontinued
Belladonna/phenobarbital tablets, 1000 count (NDC 64125-0128-10), Excellium - discontinued
Reason for the Shortage
- PBM Pharmaceuticals could not provide a reason for the shortage.
- Qualitest, Vintage, and Excellium were unable to provide a reason for the discontinuation of their generic belladonna/phenobarbital products.
- Belladonna alkaloids with phenobarbital are not FDA-approved products.
Estimated Resupply Dates
- PBM Pharmaceuticals has Donnatal tablets available in 100 count (NDC 66213-0425-10) and 1000 count (NDC 66213-0425-11) bottles. They also have Donnatal extended release tablets available in 100 count bottles (NDC 66213-0421-10) and 500 count bottles (NDC 66213-0421-50). Donnatal elixir is on back order and the company cannot estimate a release date.
- Westward has available belladonna with phenobarbital tablets in 1000 count bottles (NDC 00143-1140-10) and 5000 count bottles (NDC 00143-1140-51).
Related Shortages
Updated
October 15, 2009; September 22, 2009; August 25, 2009; July 29, 2009; July 7, 2009, University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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