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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- Hazard
- product-mix-up
- incorrect-diluent
- improper-reconstitution
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.
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