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Benztropine Injection

[18 September 2014]

Products Affected - Description

Benztropine injection, American Regent
1 mg/mL, 2 mL vials (NDC 00517-0785-05)

Benztropine injection, Fresenius Kabi
1 mg/mL, 2 mL vials (NDC 63323-0970-02)

Benztropine injection, Nexus
1 mg/mL, 2 mL vials (NDC 14789-0300-02)

Reason for the Shortage

  • American Regent has benztropine injection on back order due to manufacturing delays.
  • Fresenius Kabi USA recalled benztropine injection due to potential for glass particles in the vials. Product may have been under APP or Nexus labels. Detailed information on the recall can be found online.

Available Products

Benztropine injection, Akorn
1 mg/mL, 2 mL ampules (NDC 17478-0012-02)

Cogentin injection, Akorn
1 mg/mL, 2 mL ampules (NDC 76478-0611-02)

Benztropine injection, West-Ward
1 mg/mL, 2 mL ampules (NDC 00143-9729-05)

Estimated Resupply Dates

  • American Regent has benztropine injection on back order and the company cannot estimate a release date.
  • Fresenius Kabi USA has benztropine injection on long-term back order and the company cannot estimate a release date. Both labels from Fresenius Kabi and Nexus are affected.

Updated

September 18, 2014; July 31, 2014; June 11, 2014; May 8, 2014; March 4, 2014; January 29, 2014; December 16, 2013; December 4, 2013; October 29, 2013; September 26, 2013; August 28, 2013; July 18, 2013, 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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