Amneal Pharmaceuticals of New York, LLC recalls Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 1…

Recall date

March 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0442-2024

FDA classification

Class I

Brand / firm

Amneal Pharmaceuticals of New York, LLC

Sold / distributed

Nationwide in the USA.

Why it was recalled

Superpotent Drug: Due to overfilling of drug powder

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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