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Labor Drug Recalled


May 03, 2019

A lack of sterility assurance has caused CMC Enterprise Pharmacy to issue a recall for oxytocin 30 units in NS 500-mL bags, according to the May 1, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall is for 3690 bags distributed in North Carolina from the following lots: EA241909 (Exp. 4/24/19), EA281909 (Exp. 4/28/19), EA301910 (Exp. 4/30/19), EB111909 (Exp. 5/12/19), EB141909 (Exp. 5/15/19), EB221908 (Exp. 5/23/19), EC061908 (Exp. 6/4/19), EC131909 (Exp. 6/11/19), and EC261910 (Exp. 6/24/19). 

CMC Enterprise Pharmacy voluntarily issued the recall April 12, 2019. The FDA designated the recall Class II on April 23, 2019, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm. 

Oxytocin is a natural hormone used to improve contractions during labor or reduce bleeding after childbirth.

 Jolynn Tumolo

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