Why it was recalled
Product Mix-up: Incorrect diluent component included in the kit.
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.
Lot numbers, UPCs & expiration codes
Lot # 21035, Exp 7/31/2022
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0003-2022
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 24, 2021
- FDA report date
- Oct 13, 2021
- Quantity
- 2,751 kits
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Azurity Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0003-2022, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 88547
- Address
- 841 Woburn St
- Code information
- Lot # 21035, Exp 7/31/2022
- Postal code
- 01887-3414
- Report date
- Oct 13, 2021
- Product type
- Drugs
- Recall number
- D-0003-2022
- Classification
- Class I
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Product quantity
- 2,751 kits
- Termination date
- May 12, 2022
- Reason for recall
- Product Mix-up: Incorrect diluent component included in the kit.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- USA nationwide
- Recall initiation date
- Aug 24, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2021