Why it was recalled
Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
Product description
Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
Lot numbers, UPCs & expiration codes
Lot # A906423, exp. date Nov 2021.
Where it was sold
Nationwide
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-0247-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 21, 2021
- FDA report date
- Feb 10, 2021
- Quantity
- 46,479 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0247-2021, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 87195
- Address
- Harborplace Tower
- Address (line 2)
- 111 S Calvert St Fl 21st
- Code information
- Lot # A906423, exp. date Nov 2021.
- Postal code
- 21202-6174
- Report date
- Feb 10, 2021
- Product type
- Drugs
- Recall number
- D-0247-2021
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 46,479 bottles
- Termination date
- Dec 16, 2021
- Reason for recall
- Failed Impurities/Degradation Specifications; Out-of-specification test results observed for Impurity C at 9 month long-term stability time point.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oseltamivir Phosphate for Oral Suspension, 6 mg/mL, 60 mL (usable volume after constitution), Rx only, Manufactured for:Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad, Maharashtra, India. NDC: 68180-678-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 21, 2021
- Initial firm notification
- Letter
- Center classification date
- Feb 3, 2021