Drug 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.
D-0337-2019
Product summary
- Firm
- Tris Pharma Inc.
- Event
- Event 81354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20,736 bottles
- Official record key
drug-enforcement:D-0337-2019
Official wording
Reason: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Code information: Lot #: 00717024A, Exp 08/19
Distribution pattern: One distributor in PA who further distributed Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
Superpotent