FDA Recall D-0003-2022
Azurity Pharmaceuticals, Inc. · Wilmington, MA
Class I — life-threatening Terminated 261 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence 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.
Reason for recall
Product Mix-up: Incorrect diluent component included in the kit.
Recall record
- Recall number
D-0003-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide
- Recall initiated
- 2021-08-24
- Classified by FDA Center
- 2021-10-05
- FDA published
- 2021-10-13
- Terminated
- 2022-05-12
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Firm location
- Wilmington, MA
Drug identification
- Brand name(s)
- FIRVANQ
- Generic name(s)
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer(s)
- Azurity Pharmaceuticals, Inc
- NDC(s)
65628-204, 65628-205, 65628-206, 65628-208