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
Reported: April 24, 2024 Initiated: March 21, 2024 #D-0442-2024
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
Details
- Recalling Firm
- Amneal Pharmaceuticals of New York, LLC
- Units Affected
- 821 bottles
- Distribution
- Nationwide in the USA.
- Location
- Brookhaven, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 821 bottles.
Why was this product recalled? ▼
Superpotent Drug: Due to overfilling of drug powder
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 24, 2024. Severity: Critical. Recall number: D-0442-2024.
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