Drug 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
D-0442-2024
Product summary
- Event
- Event 94262
- Status
- Terminated
- Classification
- Class I
- Quantity
- 821 bottles
- Official record key
drug-enforcement:D-0442-2024
Official wording
Reason: Superpotent Drug: Due to overfilling of drug powder
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
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent