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 Family Dollar Services, Inc., 10301 Monroe Road, Matthews, NC 28105, NDC 55319-250-23, UPC 0 32251 03374 2.
D-0336-2019
Product summary
- Firm
- Tris Pharma Inc.
- Event
- Event 81354
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,488 bottles
- Official record key
drug-enforcement:D-0336-2019
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