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.
Reported: October 13, 2021 Initiated: August 24, 2021 #D-0003-2022
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.
Details
- Recalling Firm
- Azurity Pharmaceuticals, Inc.
- Units Affected
- 2,751 kits
- Distribution
- USA nationwide
- Location
- Wilmington, MA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Azurity Pharmaceuticals, Inc.. Units affected: 2,751 kits.
Why was this product recalled? ▼
Product Mix-up: Incorrect diluent component included in the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 13, 2021. Severity: Critical. Recall number: D-0003-2022.
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