Why it was recalled
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
Product description
Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
Lot numbers, UPCs & expiration codes
Lot#: 4718, Exp 12/19
Where it was sold
One distributor who further distributed 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-0493-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 15, 2019
- FDA report date
- Feb 20, 2019
- Quantity
- 46,080 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Tris Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0493-2019, exactly as published.
Show all FDA fields
- City
- Monmouth Junction
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81960
- Address
- 2033 US Highway 130
- Code information
- Lot#: 4718, Exp 12/19
- Postal code
- 08852-3003
- Report date
- Feb 20, 2019
- Product type
- Drugs
- Recall number
- D-0493-2019
- Classification
- Class II
- Recalling firm
- Tris Pharma Inc.
- Product quantity
- 46,080 bottles
- Termination date
- Mar 29, 2023
- Reason for recall
- Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 39338 3, NDC 59779-925-23.
- Distribution pattern
- One distributor who further distributed Nationwide in the USA.
- Recall initiation date
- Jan 15, 2019
- Initial firm notification
- Letter
- Center classification date
- Feb 14, 2019