Class I
Terminated
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
This recall has been terminated (originally issued April 24, 2024).
- Recall Initiated
- March 21, 2024
- Posted
- April 24, 2024
- Recall Number
- D-0442-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 821 bottles
- Firm Location
- Brookhaven, NY, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug: Due to overfilling of drug powder
Distribution
Nationwide in the USA.
Lot / Code Info
Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
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