Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL recall — FDA D-0442-2024
Superpotent Drug: Due to overfilling of drug powder
Overview of recall records associated with Amneal Pharmaceuticals of New York, LLC, including dates, categories and classifications where available.
Classification mix: Class III: 1, Class II: 1, Class I: 1.
Superpotent Drug: Due to overfilling of drug powder
Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number…
This page summarizes recall records in which the official source identifies Amneal Pharmaceuticals of New York, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.