March 15, 2018
Apollo Care is recalling certain vancomycin 1.25 g added to 250 mL of 0.9% sodium chloride IV bags (NDC 71170-264-25) and vancomycin 1 g added to 250 mL of 0.9% sodium chloride IV bags (NDC 71170-254-25), according to the March 14, 2018, US Food and Drug Administration (FDA) Enforcement Report.
The product’s stability data does not support its 90-day expiration date, the FDA reported.
Included in the recall are:
- 312 IV bags containing vancomycin 1.25 g added to 250 mL of 0.9% sodium chloride from lot AC-015560, which has a March 14, 2018, expiration date, and
- 360 IV bags containing vancomycin 1 g added to 250 mL of 0.9% sodium chloride from lot AC-015558, which has a March 7, 2018, expiration date.
The IV bags were distributed to medical facilities in Missouri.
Apollo Care voluntarily initiatied the recall February 15, 2018. The FDA designated the recall Class II March 6, 2018, indicating use of the affected IV bags could cause a temporary health problem.
Intravenous vancomycin is an antibiotic used to treat patients with severe bacterial infections.
For more Pharmacy Learning Network articles, visit the homepage
To learn about Pharmacy Learning Network Live meetings, click here