Amneal Pharmaceuticals of New York, LLC: Drug Recall

Recall Details

Recall Number

D-0442-2024

Classification

Class I

Product Type

Drug

Recalling Firm

Amneal Pharmaceuticals of New York, LLC

Status

Terminated

Date Initiated

03/21/2024

Location

Brookhaven, NY, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

821 bottles

Reason for Recall

Superpotent Drug: Due to overfilling of drug powder

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

Distribution Pattern

Nationwide in the USA.

Other Recalls by Amneal Pharmaceuticals of New York, LLC

• Class II: Risk 03/25/2024
  Failed Dissolution Specifications
• Class II: Risk 02/13/2024
  Failed Impurities/Degradation Specifications: Out-of-specification test results.
• Class II: Risk 01/15/2024
  Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
• Class II: Risk 12/26/2023
  Failed dissolution specifications
• Class II: Risk 10/27/2023
  Failed Dissolution Specifications

View all recalls by Amneal Pharmaceuticals of New York, LLC →