Drug recall D-0003-2022

Class I Terminated reported Oct 13, 2021

Product

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.

Reason for recall

Product Mix-up: Incorrect diluent component included in the kit.

Lots and codes

Lot # 21035, Exp 7/31/2022

Recall details

Recalling firm
Azurity Pharmaceuticals, Inc., Wilmington, MA
Quantity
2,751 kits
Distribution
USA nationwide
Type
Voluntary: Firm initiated
Recall initiated
August 24, 2021
Terminated
May 12, 2022

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