Bulletin
Esterified Estrogens and Methyltestosterone Tablets
05 November 2009
Products Affected - Description
Esterified Estrogens 1.25 mg and Methyltestosterone 2.5 mg Tablets
Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 51991-0079-01), Breckenridge
Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 53746-0078-01), Amneal
Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 68462-0173-01), Glenmark
Esterified Estrogens/Methyltestosterone, 100 count bottles (NDC 00527-1410-01), Lannett
Esterified Estrogens 0.625 mg and Methyltestosterone 1.25 mg Tablets
Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 51991-0078-01), Breckenridge
Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 53746-0077-01), Amneal
Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 68462-0174-01), Glenmark
Esterified Estrogens/Methyltestosterone HS, 100 count bottles (NDC 00527-1409-01), Lannett
Reason for the Shortage
- Centrix and Breckenridge products were in short supply due to a raw material shortage.
- Amneal was unable to provide a reason for the shortage.
- Glenmark and Lannett are unable to provide a reason for the shortage.
- Prasco Labs discontinued Essian and Essian HS in May, 2009.
- Solvay discontinued Estratest and Estratest HS in March, 2009.
Estimated Resupply Dates
- Centrix has available Covaryx (NDC 11528-0010-01) in 100 count bottles and Covaryx HS (NDC 11528-0020-01) in 100 count bottles.
- Breckenridge has both of their esterified estrogens/methyltestosterone products on back order and estimate a release date of mid-to-late November, 2009.
- Amneal has both of their esterified estrogens/methyltestosterone products on back order and cannot estimate a release date.
- Glenmark has both of their esterified estrogens/methyltestosterone products on back order and cannot estimate a release date.
- Lannett has both of their esterified estrogens/methyltestosterone products on intermittent back order and the company is releasing supplies as they become available.
- Creekwood Pharma has available EEMT 1.25 mg/2.5 mg tablets in 100 count bottles (NDC 15310-0010-01) and EEMT HS 0.625 mg/1.25 mg tablets in 100 count bottles (NDC 15310-0020-01).
Updated
November 5, 2009; October 8, 2009; July 31, 2009, University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
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