[22 August 2012]
Products Affected - Description
Dynacirc CR, GSK
5 mg extended-release tablets, 30 count (NDC 00173-0784-01) - discontinued
10 mg extended-release tablets, 30 count (NDC 00173-0785-01) - discontinued
Reason for the Shortage
- Novartis voluntarily suspended all manufacturing and distribution from its Lincoln, Nebraska facility in early-January 2012 due to a potential for mixing of different products within a single bottle. Novartis is gradually resuming manufacturing at this facility after manufacturing improvements were implemented.
- GlaxoSmithKline’s Dynacirc CR tablets are manufactured at the Lincoln, Nebraska plant and are affected by this manufacturing suspension. The majority of medications made at this facility were over the counter products. However, some prescription products were affected including contracted items from other companies.
- The immediate release presentations are supplied by Watson Labs.
Isradipine, Watson Labs
2.5 mg capsules, 100 count (NDC 16252-0539-01)
5 mg capsules, 100 count (NDC 16252-0540-01)
Estimated Resupply Dates
- GlaxoSmithKline discontinued Dynacirc CR 5 mg and 10 mg tablets on August 6, 2012.
- All other presentations are available.
August 22, 2012; June 20, 2012; April 20, 2012; March 13, 2012, University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.
This information is provided through the support of Novation to ASHP solely as a service to its members, which shall not use this information for their further commercial use. The content was prepared by the Drug Information Center of University of Utah. Novation, ASHP, and the University of Utah make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, which respect to such information, and specifically disclaim all such warranties. Users of this information are advised that decisions regarding the use of drugs and drug therapies are complex medical decisions and that in using this information, each user must exercise his or her own independent professional judgment. Neither Novation, ASHP nor the University of Utah assumes any liability for persons administering or receiving drugs or other medical care in reliance upon this information, or otherwise in connection with this bulletin. Neither Novation, ASHP nor University of Utah endorses or recommends the use of any drug.
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