April 06, 2018
Apollo Care is recalling additional vancomycin IV bags because their 90-day beyond-use dates are not supported by stability data. The recall, included in the April 4, 2018, US Food and Drug Administration (FDA) Enforcement Report, extends a previous recall the FDA announced last month.
The latest recall affects the following products:
- 144 IV bags containing vancomycin 1 g added to 250 mL of 0.9% sodium chloride (NDC 71170-254-25) from lot AC-015565 (Exp. 3/26/18), and
- 96 IV bags containing vancomycin 1.25 g added to 250 mL of 0.9% sodium chloride (NDC 71170-254-25) from lot AC-015569 (Exp. 3/26/18).
The bags were distributed to medical facilities in Missouri.
Apollo Care voluntarily issued the additional recall March 7, 2018. The FDA designated it Class II March 29, 2018. The classification suggests use of affected IV bags could cause temporary adverse health consequences. The probability of serious harm is remote.
Intravenous vancomycin is an antibiotic used to treat patients with severe bacterial infections.
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