Firvanq Vancomycin Oral Solution Kits Recalled for Incorrect Diluent
Azurity Pharmaceuticals is recalling 2,751 kits of Firvanq (vancomycin hydrochloride for oral solution) distributed nationwide because an incorrect diluent component was included in the kit.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall of a prescription drug product. Class I recalls are automatically classified as Severe (score 4) or Critical (score 5) per the rubric. No deaths or serious injuries are reported in the source text, so the classification is Severe.
Plain-English summary
Azurity Pharmaceuticals, Inc. is recalling Firvanq (vancomycin hydrochloride for oral solution), 50 mg/mL kit, Lot # 21035, expiration date 7/31/2022. A total of 2,751 kits were distributed nationwide. Each kit is intended to include one bottle containing 7.7 g vancomycin hydrochloride USP powder for oral solution and one bottle containing 145 mL grape-flavored diluent for reconstitution.
The recall was initiated because an incorrect diluent component was included in the kit. This product mix-up poses a risk that patients may receive improperly reconstituted medication.
Patients and healthcare providers who have this product should discontinue use and contact Azurity Pharmaceuticals or their healthcare provider for guidance on obtaining properly reconstituted Firvanq or an alternative treatment option.
The recalled product
- Product
- FIRVANQ (VANCOMYCIN HYDROCHLORIDE)
- Brand
- FIRVANQ
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Affected units
- 2,751
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 21035
- Exp 7/31/2022
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Azurity Pharmaceuticals, Inc.
See all →- CriticalFDA Recalls Zenzedi Dextroamphetamine Sulfate Due to Label Mix-up
FDA (Drugs) · 2024-02-07
- ModeratePrescription Oral Solution Eprontia Recalled for Out-of-Specification Impurity
FDA (Drugs) · 2024-01-10
- HighTestosterone Cypionate Injection Recalled for Manufacturing Defect
FDA (Drugs) · 2023-04-12
Same hazard · product mix up
See all →- HighAripiprazole 30mg bottle contained voriconazole 50mg tablets instead
FDA (Drugs) · 2026-06-24
- HighLisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet
FDA (Drugs) · 2025-07-23
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- HighKWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
FDA (Devices) · 2025-06-18
- HighStryker 3.0MM Neuro Precision Head Recalled for Package Labeling Mismatch
FDA (Devices) · 2025-01-29
Similar recalls
- ModerateAuroMedics Recalls Vancomycin Hydrochloride Vials Due to Discoloration
FDA (Drugs) · 2019-12-18
- SevereRXQ Compounding Recalls Pyridoxine Vials Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- SevereUS Compounding Recalls Vancomycin Ophthalmic Preparations Due to Sterility Concerns
FDA (Drugs) · 2015-11-25
- SevereVancomycin Hydrochloride Oral Solution Recalled Nationwide for Superpotency Due to Overfilling
FDA (Drugs) · 2024-04-24
- HighVancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2016-06-15
- SevereUS Compounding Recalls Zinc Sulfate Vials Due to Sterility Concerns
FDA (Drugs) · 2015-11-25