Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit, Each Kit Includes:...

FDA Drug Recall #D-0003-2022 — Class I — August 24, 2021

Recall Summary

Recall Number D-0003-2022
Classification Class I — Serious risk
Date Initiated August 24, 2021
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Azurity Pharmaceuticals, Inc.
Location Wilmington, MA
Product Type Drugs
Quantity 2,751 kits

Product Description

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.

Distribution Pattern

USA nationwide

Lot / Code Information

Lot # 21035, Exp 7/31/2022

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D-0489-2023 Class II Testosterone Cypionate Injection, USP, CIII, 20... Feb 15, 2023

Frequently Asked Questions

Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.