FDA-Drug2021-10-13Class I
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Azurity Pharmaceuticals, Inc.
Hazard
Product Mix-up: Incorrect diluent component included in the kit.
Sold states
USA nationwide
Affected count
2,751 kits
Manufactured in
841 Woburn St, Wilmington, MA, United States
Products
Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes: 1 bottle containing 7.7 g Vancomycin Hydrochloride USP, powder for oral solution and 1 bottle containing 145 mL Grape Flavored Diluent for reconstitution per carton, Rx only, Manufactured for: Azurity pharmaceuticals, Wilmington, MA 01887, NDC 65628-206-05.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0003-2022Don't want to check this manually?
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