Firvanq — Class I drug recall D-0003-2022
Terminated recall by Azurity Pharmaceuticals, Inc., reported 2021-10-13, distributed nationwide. Product Mix-up: Incorrect diluent component included in the kit.
| Recall number | D-0003-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Azurity Pharmaceuticals, Inc., Wilmington, MA, United States |
| Recall initiated | 2021-08-24 |
| Classified | 2021-10-05 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2022-05-12 |
| Distributed | Nationwide (US) |
| Quantity | 2,751 kits |
| NDC | 65628-0204, 65628-0204-05, 65628-0205, 65628-0205-10, 65628-0206, 65628-0206-05, 65628-0208, 65628-0208-10 |
| Lot numbers | 21035 |
| Expiration dates | 2022-07-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0003-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.