FDA recall D-0442-2024

Amneal Pharmaceuticals of New York, LLC · Class I · drug

Product

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

Distribution

Nationwide in the USA.

Key facts

Status: Terminated
Initiation date: 2024-03-21
Report date: 2024-04-24
Termination date: 2025-07-21
Voluntary/Mandated: Voluntary: Firm initiated
Location: Brookhaven, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0442-2024