Home / Recalls / Tris Pharma Inc. / D-0335-2019

D-0335-2019 Class II Terminated

Recalled by Tris Pharma Inc. — Monmouth Junction, NJ

Recall Details

Product Type
Drugs
Report Date
December 26, 2018
Initiation Date
November 26, 2018
Termination Date
April 1, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
164,304 bottles

Product Description

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.

Reason for Recall

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

Distribution Pattern

One distributor in PA who further distributed Nationwide in the USA.

Code Information

Lot #: 00717009A, Exp 02/19; 00717015A, Exp 04/19; 00717024A, Exp 08/19

Other recalls by Tris Pharma Inc.

  • D-1517-2019 Class II — Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspensi (July 11, 2019)
  • D-0493-2019 Class II — Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg (January 15, 2019)
  • D-0494-2019 Class II — infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg p (January 15, 2019)
  • D-0495-2019 Class II — Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg (January 15, 2019)
  • D-0337-2019 Class II — Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg (November 26, 2018)
  • D-0336-2019 Class II — Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg (November 26, 2018)
  • D-1126-2017 Class II — Morphine Sulfate Oral Solution, 100 mg/ 5 mL (20 mg/mL), packaged in a 1 oz. bot (June 15, 2017)