FDAFDA · Food and drugs·Recall number D-0442-2024
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
Published April 24, 2024 · Recall initiated: March 21, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: Due to overfilling of drug powder
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- VANCOMYCIN HYDROCHLORIDE
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Distributor
- Nationwide in the USA.
- UPC
- 0369238226133
- Lot
- Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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