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Isotretinoin Oral Capsules

[18 August 2014]

Products Affected - Description

Isotretinoin capsules

Reason for the Shortage

  • Teva and VersaPharm could not provide a reason for the shortage.
  • Mylan and Dr Reddy’s state the shortage was due to increased demand for the products.

Available Products

Absorica, Ranbaxy
10 mg capsules, 30 count (NDC 10631-0015-31)
20 mg capsules, 30 count (NDC 10631-0116-31)
30 mg capsules, 30 count (NDC 10631-0117-31)
40 mg capsules, 30 count (NDC 10631-0118-31)

Amnesteem, Mylan
10 mg capsules, 30 count (NDC 00378-6611-93)
20 mg capsules, 30 count (NDC 00378-6614-93)
30 mg capsules, 30 count (NDC 00378-6612-93)

Claravis, Teva
10 mg capsules, 30 count (NDC 00555-1054-86)
10 mg capsules, 100 count (NDC 00555-1054-56)
20 mg capsules, 30 count (NDC 00555-1055-86)
20 mg capsules, 100 count (NDC 00555-1055-56)
30 mg capsules, 30 count (NDC 00555-1056-86)
40 mg capsules, 30 count (NDC 00555-1057-86)
40 mg capsules, 100 count (NDC 00555-1057-56)

Myorisan, VersaPharm
10 mg capsules, 30 count (NDC 61748-0301-13)
10 mg capsules, 100 count (NDC 61748-0301-11)
20 mg capsules, 30 count (NDC 61748-0302-13)
20 mg capsules, 100 count (NDC 61748-0302-11)
40 mg capsules, 30 count (NDC 61748-0304-13)
40 mg capsules, 100 count (NDC 61748-0304-11)

Zenatane, Dr Reddy’s
10 mg capsules, 30 count (NDC 55111-0135-81)
20 mg capsules, 30 count (NDC 55111-0136-81)
40 mg capsules, 30 count (NDC 55111-0137-81) 

Estimated Resupply Dates

All presentations are available.

Implications for Patient Care

Amnesteem, Myorisan, and Zenatane are therapeutic equivalents of Claravis, and may be substituted for one another. Absorica is not a therapeutic equivalent of Claravis, and may not be substituted with the other products. Refer to the FDA Orange Book for additional information.

Related Shortages

Updated

August 18, 2014; June 26, 2014; May 21, 2014; April 29, 2014, University of Utah, Drug Information Service. Copyright 2014, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

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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