Sterility Concerns Prompt Recall of Several Vancomycin Products

CMC Enterprise Pharmacy is recalling several vancomycin products distributed in North Carolina because of concerns over sterility, according to the May 1, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following products: 

• vancomycin 1000 mg in NS 250-mL bags from lots ED041918 (Exp. 4/13/19), ED051918 (Exp. 4/14/19), ED081918 (Exp. 4/17/19), ED091918 (Exp. 4/18/19), ED101918 (Exp. 4/19/19), and ED111916 (Exp. 4/20/19); 
• vancomycin 1250 mg in NS 250-mL bags from lots ED041915 (Exp. 4/13/19), ED051915 (Exp. 4/14/19), ED081915 (Exp. 4/17/19), ED091915 (Exp. 4/18/19), ED101915 (Exp. 4/19/19), and ED111913 (Exp. 4/20/19); 
• vancomycin 1500 mg in NS 250-mL bags from lots ED041916 (Exp. 4/13/19), ED051916 (Exp. 4/14/19), ED081916 (Exp. 4/17/19), ED091916 (Exp. 4/18/19), ED101916 (Exp. 4/19/19), and ED111914 (Exp. 4/20/19); 
• vancomycin 1750 mg in 0.9% sodium chloride 500-mL bags from lots ED041918 (Exp. 4/13/19), ED051917 (Exp. 4/14/19), ED081917 (Exp. 4/17/19), ED091917 (Exp. 4/18/19), ED1019117 (Exp. 4/19/19), and ED111915 (Exp. 4/20/19); and
• vancomycin 2000 mg in 0.9% sodium chloride 500-mL bags from lots ED041919 (Exp. 4/13/19), ED051919 (Exp. 4/14/19), ED041919 (Exp. 4/17/19), ED091919 (Exp. 4/18/19), ED101919 (Exp. 4/19/19), and ED111917 (Exp. 4/20/19). 

CMC Enterprise Pharmacy voluntarily issued the recall April 12, 2019. On April 23, 2019, the FDA designated it a Class II recall, communicating use of the product could cause temporary or medically reversible adverse health consequences. Although the likelihood is remote, a possibility of serious harm also exists. 

Vancomycin is an antibiotic drug used to treat bacterial infections in different parts of the body. 

—Jolynn Tumolo