Infants' Ibuprofen recall: Superpotent
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.
Why was Infants' Ibuprofen recalled?
Superpotent Drug: recalled lots may have higher concentration of ibuprofen than amount labeled.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot#: 4718, Exp 12/19
- Product
- 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.
- Recalling firm
- Tris Pharma Inc.
- Quantity
- 46,080 bottles
- Distribution
- One distributor who further distributed Nationwide in the USA.
- Recall date
- February 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)