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Recall Ongoing for Hypotension Treatment

August 14, 2017

Ephedrine sulfate 5 mg/mL in normal saline, 5-mL fill in 12-mL syringe (25 mg, NDC 70004-0600-11), is being recalled by SCA Pharmaceuticals. The August 2, 2017, US Food and Drug Administration (FDA) Enforcement Report included the voluntary recall, which was prompted by sterility concerns.

The recalled syringes are from 2 lots: 20170503@28 (beyond-use date 7/17/17) and 20170508@60 (beyond-use date 7/22/17). The recalled syringes were distributed throughout the United States.

SCA Pharmaceuticals issued the voluntary recall July 14, 2017. The FDA designated it Class II July 26, 2017, indicating exposure to the syringes could cause temporary or medically reversible adverse health effects. However, the likelihood of serious harm is small.

Ephedrine sulfate injection is used to treat abnormally low blood pressure in anesthesia settings.

Jolynn Tumolo

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