Status
Terminated
Drug Enforcement D-0442-2024
Superpotent Drug: Due to overfilling of drug powder
Classification
Class I
Report Date
April 24, 2024
Termination Date
July 21, 2025
Product Information
- 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
- Product quantity
- 821 bottles
- Reason for recall
- Superpotent Drug: Due to overfilling of drug powder
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA.
Location & Firm
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Address
-
50 Horseblock Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0442-2024
- Event ID
- 94262
- Recall initiation date
- March 21, 2024
- Center classification date
- April 12, 2024
- 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
- More code info
- —