The Recall Desk

FDA (Drugs) recall action 81354

Tris Pharma Inc. recalled 3 products on 2018-12-26

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-12-26
Critical
0
Units
204,528

Why these products were recalled

Superpotent Drug: recalled lots may have higher concentration of ibuprofen.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Drugs)··2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of Infants' Ibuprofen because they may contain a higher concentration of the active ingredient.

    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2018-12-26

    Tris Pharma Recalls Superpotent Infants' Ibuprofen Suspension

    Tris Pharma is recalling 19,488 bottles of Infants' Ibuprofen due to potential higher-than-labeled ibuprofen concentrations.

    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.
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2018-12-26

    Tris Pharma Recalls Infants' Ibuprofen Due to Higher Concentration

    Tris Pharma is recalling specific lots of infants' ibuprofen oral suspension because they may contain a higher concentration of the active ingredient.

    Product
    infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 FL OZ (15 mL) bottle, Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 49035-125-23, UPC 0 78742 02016 7.
    Category
    Distribution
    1 state