Benztropine Injection

[04 November 2015]

Products Affected - Description

Cogentin injection, Akorn
1 mg/mL, 2 mL ampule, 5 count (NDC 76478-0611-02)
Benztropine intravenous injection, Akorn
1 mg/mL, 2 mL ampules, 5 count (NDC 17478-0012-02)
Benztropine intravenous injection, American Regent
1 mg/mL, 2 mL vials, 5 count (NDC 00517-0785-05) - discontinued

Benztropine intravenous injection, Fresenius Kabi
1 mg/mL, 2 mL vials, 5 count (NDC 63323-0970-02)
Benztropine intravenous injection, Nexus Pharmaceuticals
1 mg/mL, 2 mL vials, 5 count (NDC 14789-0300-02) - discontinued

Reason for the Shortage

  • American Regent discontinued benztropine injection in May 2015.
  • Fresenius Kabi recalled benztropine injection due to potential for glass particles in the vials. The product is on long-term back order.
  • Nexus divested benztropine injection to Fresenius Kabi in 2012.

Available Products

Benztropine Mesylate injection, West-Ward
1 mg/mL, 2 mL ampule, 5 count (NDC 00143-9729-05)

Estimated Resupply Dates

  • Akorn has benztropine injection and Cogentin injection on back order and the company estimates a release date in December 2015.
  • Fresenius Kabi has benztropine injection on long-term back order and the company cannot estimate a release date.


November 4, October 19 and 12, August 20 and 19, July 23, June 11 and 9, April 30, March 25, February 11, January 26 and 7, 2015; September 18, July 31, June 11, May 8, March 4, January 29, 2014; December 16 and 4, October 29, September 26, August 28, July 18, 2013, University of Utah, Drug Information Service. Copyright 2015, Drug Information Service, University of Utah, Salt Lake City, UT.


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