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1/30/2020

Hypromellose Ophthalmic Solution

Products Affected - Description

    • Gonak, Akorn, 2.5%, 15 mL NDC 17478-0064-12
    • Goniosoft, OCuSOFT, 2.5%, 15 mL NDC 54799-0503-15
    • Goniotaire, Altaire, 2.5%, 15 mL NDC 59390-0182-13

Reason for the Shortage

    • Akorn has Gonak on shortage due to lack of raw materials.1
    • HUB Pharmaceuticals is planning on relaunching Goniovisc in late-2020.2
    • Altaire has Goniotaire on shortage due to a voluntary recall.[3]
    • OcuSoft did not provide a reason for the shortage.[4]

Available Products

    • There is insufficient supply for usual ordering

Estimated Resupply Dates

    • Akorn has Gonak 2.5% ophthalmic solution 15 mL bottles on back order and the company cannot estimate a release date.1
    • Altaire has Goniotaire 2.5% ophthalmic solution 15 mL bottles on back order and the company cannot estimate a release date.[3]
    • Hub Pharmaceuticals has Goniovisc on long-term back order and the company estimates a relaunch date of late-2020.[2]
    • OCuSOFT has Goniosoft 2.5% ophthalmic solution on back order and the company cannot estimate a release date.4

Alternative Agents & Management

    • Hypromellose-containing products are used in ocular examinations and to treat dry eye.[5] There are products available ranging from hypromellose 0.2% to 2.5%.[5] The American Academy of Ophthalmology does not recommend a specific product over another.[6] Use products without preservatives if applying more than 4 times daily.[6]

References

    1. Akorn (personal communication). June 8, July 13, September 7, October 25, December 13 and 26, 2018; March 1, May 8, July 29, September 17, December 18, 2019; and January 30, 2020.
    2. HUB Pharmaceuticals (personal communication). June 8, July 11, September 5, October 25, December 13, 2018; May 8, July 29, September 13, October 2, December 18, 2019; and January 28, 2020.
    3. Altaire Pharmaceuticals (personal communication). June 8, July 11, September 5, October 25, December 13, 2018; May 8 and 22, September 17, and December 18, 2019.
    4. Ocusoft/Cynacon (personal communication). June 8, July 11, September 5, October 25, December 13, 2018; May 8, July 29, September 17, and December 18, 2019.
    5. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc; 2018.
    6. American Academy of Ophthalmology Cornea/External Disease Panel. Preferred Practice Patern Guidelines. Dry Eye Syndrome. American Academy of Ophthalmology website. www.aao.org/ppp. 2013. Accessed June 11, 2018.

Updated

Updated January 30, 2020 by Michelle Wheeler, PharmD, Drug Information Specialist. Created June 8, 2018 by Anthony Trovato, PharmD, BCPS. © 2020, Drug Information Service, University of Utah, Salt Lake City, UT.

Disclaimer

Drug Shortage Bulletins are copyrighted by the Drug Information Service of the University of Utah and provided by ASHP as its exclusive authorized distributor. 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, with 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 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 ASHP nor the University of Utah endorses or recommends the use of any particular drug. Any application of this information for any purpose shall be limited to personal, non-commercial use.

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