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Sterility Concerns Prompt Recall of Several Vancomycin Products
05/03/2019
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