Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification test results.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0327-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 13, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 46,037 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
Original FDA data
Every field from FDA enforcement report D-0327-2024, exactly as published.
Show all FDA fields
- City
- Brookhaven
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 93959
- Address
- 50 Horseblock Rd
- Code information
- Lot # BF22722A, Exp. 08/31/2024; BJ15122A, Exp. 09/30/2024
- Postal code
- 11719-9509
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0327-2024
- Classification
- Class II
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- Product quantity
- 46,037 Bottles
- Termination date
- Feb 14, 2025
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification test results.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 13, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 16, 2024