CLASS I Drug recall · Reported 13 Oct 2021 · FDA Enforcement Report
Firvanq (vancomycin hydrochloride for oral solution) recalled
Azurity Pharmaceuticals is recalling Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit, distributed nationwide in the US. The recall was initiated on 24 Aug 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0003-2022
- FDA event ID
- 88547
- Recalling firm
- Azurity Pharmaceuticals, Wilmington, MA
- Brand
- Firvanq
- Manufacturer
- Azurity Pharmaceuticals, Inc
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 Aug 2021
- FDA classified
- 5 Oct 2021
- Reported
- 13 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Antibiotics
Timeline
| 24 Aug 2021 | Recall initiated by company | |
| 5 Oct 2021 | Classified by FDA | +42 days |
| 13 Oct 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product Mix-up: Incorrect diluent component included in the kit.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
USA nationwide
Questions about this recall
Why was it recalled?
Product Mix-up: Incorrect diluent component included in the kit.
Which lots are affected?
Lot # 21035, Exp 7/31/2022
Where was it sold?
USA nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Azurity Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS I | Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg recalledZenzedi | Azurity Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS III | Eprontia (topiramate) oral solution, 25 mg/mL recalledEprontia | Azurity Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate | Azurity Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Vancomycin recalls
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vancomycin Injection, USP in 5% Dextrose per (5 mg/mL) recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Vancomycin Injection, USP, in 0.9% Sodium Chloride recalledVancomycin Hydrochloride | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Vancomycin 1 MG/ Solution for Intraocular Injection Single Dose Vial recalled | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | vancomycin 750 mg/ added to 0.9% Sodium Chloride, (3 mg/mL), IV recalled | Central Admixture Pharmacy Services | Sterility | Nationwide |