Recalls / Class II
Class IID-0327-2024
Product
Oseltamivir Phosphate for Oral Suspension 6mg/ml, 60 mL (reconstituted) bottle, RX only, Distributed by Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC# 69238-1273-6
- Brand name
- Oseltamivir Phosphate
- Generic name
- Oseltamivir Phosphate
- Active ingredient
- Oseltamivir Phosphate
- Route
- Oral
- NDC
- 69238-1273
- FDA application
- ANDA210186
- Affected lot / code info
- Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification test results.
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, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- 46,037 Bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-02-13
- FDA classified
- 2024-02-16
- Posted by FDA
- 2024-02-28
- Terminated
- 2025-02-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0327-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.