[04 March 2014]
Products Affected - Description
Benztropine injection, American Regent
1 mg/mL, 2 mL vials (NDC 00517-0785-05)
Benztropine injection, Fresenius Kabi (formerly APP)
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.
- West-Ward had benztropine injection on back order due to increased demand for the product.
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.
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.
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