Drug recall D-0442-2024

Class I Terminated reported Apr 24, 2024

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

Reason for recall

Superpotent Drug: Due to overfilling of drug powder

Lots and codes

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

Recall details

Recalling firm
Amneal Pharmaceuticals of New York, LLC, Brookhaven, NY
Quantity
821 bottles
Distribution
Nationwide in the USA.
Type
Voluntary: Firm initiated
Recall initiated
March 21, 2024
Terminated
July 21, 2025

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