Recalls / Class I
Class ID-0003-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
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.
- Brand name
- Firvanq
- Generic name
- Vancomycin Hydrochloride
- NDCs
- 65628-204, 65628-205, 65628-206, 65628-208
- FDA application
- NDA208910
- Affected lot / code info
- Lot # 21035, Exp 7/31/2022
Why it was recalled
Product Mix-up: Incorrect diluent component included in the kit.
Recalling firm
- Firm
- Azurity Pharmaceuticals, Inc.
- Manufacturer
- Azurity Pharmaceuticals, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 841 Woburn St, Wilmington, Massachusetts 01887-3414
Distribution
- Quantity
- 2,751 kits
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2021-08-24
- FDA classified
- 2021-10-05
- Posted by FDA
- 2021-10-13
- Terminated
- 2022-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0003-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.