Drug 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.
D-0003-2022
Product summary
- Event
- Event 88547
- Status
- Terminated
- Classification
- Class I
- Quantity
- 2,751 kits
- Official record key
drug-enforcement:D-0003-2022
Official wording
Reason: Product Mix-up: Incorrect diluent component included in the kit.
Code information: Lot # 21035, Exp 7/31/2022
Distribution pattern: USA nationwide
Derived failure modes
-
Unknown
Product Mix-up: Incorrect diluent component included in the kit.