D-0442-2024 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 24, 2024
- Initiation Date
- March 21, 2024
- Termination Date
- July 21, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 821 bottles
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
Reason for Recall
Superpotent Drug: Due to overfilling of drug powder
Distribution Pattern
Nationwide in the USA.
Code Information
Lot # (a) 22613003A, Exp. date 09/30/2025; (b) 22613004A, 22613005A, Exp. date 09/30/2025; (c) 22613005B, Exp. date 09/30/2025