Why it was recalled
Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
Product description
Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
Lot numbers, UPCs & expiration codes
Lot #: R51129, Exp. 11/20
Where it was sold
Nationwide within the United States
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-1169-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 23, 2018
- FDA report date
- Sep 5, 2018
- Quantity
- 17,136 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Global Supply
Original FDA data
Every field from FDA enforcement report D-1169-2018, exactly as published.
Show all FDA fields
- City
- Andover
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 80876
- Address
- One Burtt Road
- Code information
- Lot #: R51129, Exp. 11/20
- Postal code
- 01810
- Report date
- Sep 5, 2018
- Product type
- Drugs
- Recall number
- D-1169-2018
- Classification
- Class II
- Recalling firm
- Pfizer Global Supply
- Product quantity
- 17,136 bottles
- Termination date
- Feb 11, 2021
- Reason for recall
- Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Aug 23, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 30, 2018