Recalls / Class I
Class ID-0442-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Vancomycin Hydrochloride
- Generic name
- Vancomycin Hydrochloride
- Active ingredient
- Vancomycin Hydrochloride
- Route
- Oral
- NDC
- 69238-2261
- FDA application
- ANDA215338
- Affected lot / 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
Why it was recalled
Superpotent Drug: Due to overfilling of drug powder
Recalling firm
- Firm
- Amneal Pharmaceuticals of New York, LLC
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 821 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2024-03-21
- FDA classified
- 2024-04-12
- Posted by FDA
- 2024-04-24
- Terminated
- 2025-07-21
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0442-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.