D-0003-2022 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 13, 2021
- Initiation Date
- August 24, 2021
- Termination Date
- May 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,751 kits
Product Description
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.
Distribution Pattern
USA nationwide
Code Information
Lot # 21035, Exp 7/31/2022