Vancomycin Hydrochloride Solution
FDA Recall NDC 69238-2261
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Vancomycin Hydrochloride (NDC 69238-2261). A significant event, classified as Class I, was initiated on Mar 21, 2024 by Amneal Pharmaceuticals Ny Llc. The reported reason for this action was: "Superpotent Drug: Due to overfilling of drug powder"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Superpotent Drug: Due to overfilling of drug powder
Mar 21, 2024
Apr 24, 2024
821 bottles
Recall Profile & Regulatory Data
Event ID
94262
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Amneal Pharmaceuticals of New York, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Jul 21, 2025
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
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
69238-2261-3Product
69238-2261-7Product
69238-2261-5Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
