FDA-Drug2023-05-31Class II

vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.

Central Admixture Pharmacy Services, Inc.
Hazard

Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.

Sold states
Nationwide in the USA.
Affected count
4390 bags
Manufactured in
6580 Snowdrift Rd Ste 100, N/A, Allentown, PA, United States
Products
vancomycin added to 0.9% sodium chloride, 1 g/250 mL* (4 mg/mL), 25 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-6064-1.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0717-2023

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