Anticholinergic Agent Recalled
Nearly 49,000 5-mL single-dose syringes of Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution were recalled across the country, as reported in the latest Enforcement Report from the US Food and Drug Administration (FDA).
Cantrell Drug Company voluntarily initiated the ongoing recall last month due to lack of sterility assurance, according to the report. The company issued a press release to announce the recall.
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The code information for the recalled syringes is as follows:
- Lot: 9006 BUD: 1/20/2017
- Lot: 8757 BUD: 11/30/2016
- Lot: 8954 BUD: 1/6/2017
- Lot: 9174 BUD: 2/20/2017
The FDA gave the recall a Class II designation on December 13. Taking a Class II recalled product “might cause a temporary health problem, or pose only a slight threat of a serious nature,” as stated on the Enforcement Report Definitions page.
Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution has several indications, including to reduce salivation preoperatively.--Meredith Edwards White
Reference:
Enforcement Report. US Food and Drug Administration Website. https://www.accessdata.fda.gov/scripts/ires/index.cfm. Published December 21, 2016. Accessed December 21, 2016.
