FDA Recall D-0442-2024

Amneal Pharmaceuticals of New York, LLC · Brookhaven, NY

Class I — life-threatening Terminated 487 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

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

Quantity: 821 bottles

Reason for recall

Superpotent Drug: Due to overfilling of drug powder

Recall record

Recall number: D-0442-2024
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2024-03-21
Classified by FDA Center: 2024-04-12
FDA published: 2024-04-24
Terminated: 2025-07-21
Recalling firm: Amneal Pharmaceuticals of New York, LLC
Firm location: Brookhaven, NY

Drug identification

Brand name(s): VANCOMYCIN HYDROCHLORIDE
Generic name(s): VANCOMYCIN HYDROCHLORIDE
Manufacturer(s): Amneal Pharmaceuticals NY LLC
NDC(s): 69238-2261
Route(s): ORAL

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