March 2024 FDA Recall Vancomycin Hydrochloride by Amneal Pharmaceuticals Of New York, Llc
D-0442-2024 - Superpotent Drug

This Class I drug recall was voluntarily initiated by Amneal Pharmaceuticals Of New York, Llc on March 21, 2024 for the product Vancomycin Hydrochloride. The FDA reported the reason for recall as superpotent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0442-2024

Reason for Recall
Superpotent Drug: Due to overfilling of drug powder
Initiated
03-21-2024
Reported
04-24-2024
Quantity
821 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94262
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
07-21-2025
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025

Affected Packages Involved in this Recall

69238-2261-3 Vancomycin Hydrochloride
69238-2261-7 Vancomycin Hydrochloride
69238-2261-5 Vancomycin Hydrochloride