Belladonna

11 March 2009

Products Affected - Description

Belladonna alkaloids/opium alkaloids 16.2 mg / 30 mg rectal suppositories
B&O Supprettes 15A (NDC 61451-5015-07), Amerifit - discontinued

Belladonna alkaloids/opium alkaloids 16.2 mg / 60 mg rectal suppositories
B&O Supprettes 16A (NDC 61451-5016-07), Amerifit - discontinued

Reason for the Shortage

• Amerifit (formerly Polymedica Pharma) had B&O Supprettes on back order due to regulatory issues. B&O Supprettes are an unapproved drug and the company was required to submit an approval application to continue marketing this product.
• Paddock Laboratories states that the B&O suppositories are on back order due to problems obtaining raw materials.

Estimated Resupply Dates

• Amerifit (formerly Polymedica Pharma) has discontinued their products.
• Paddock Laboratories has available belladonna alkaloids / opium alkaloids 16. 2 mg / 30 mg suppositories (NDC 00574-7045-12) and 16.2 mg/ 60 mg suppositories (NDC 00574-7040-12).

Related Shortages

• Dicyclomine Injection
• Glycopyrrolate Injection— Resolved
• Hyoscyamine Tablet— Resolved
• Procyclidine Tablets— No Longer Available
• Scopolamine Injection— Resolved
• Scopolamine Transdermal— Resolved

Updated

March 11, 2009; March 2, 2009; February 25, 2009; February 20, 2009; July 16, 2008; May 14, 2008; April 23, 2008; March 25, 2008; February 27, 2008; February 14, 2008; February 4, 2008; December 11, 2007; November 8, 2007; September 27, 2007; August 10, 2007. Copyright 2009, University of Utah, Drug Information Service.

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