Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, N...
FDA Recall #D-0442-2024 — Class I — March 21, 2024
Product Description
Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 150 mL bottle, NDC 69238-2261-7; (c)300 mL bottle, NDC 69238-2261-5; Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
Reason for Recall
Superpotent Drug: Due to overfilling of drug powder
Recalling Firm
Amneal Pharmaceuticals of New York, LLC — Brookhaven, NY
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
821 bottles
Distribution
Nationwide in the USA.
Code Information
Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated