RECALL: Company expands voluntary recall of infants' ibuprofen

Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.

Last month, Tris Pharma recalled three liquid ibuprofen medications.

[PAST COVERAGE: Infant ibuprofen sold at Walmart, CVS, Family Dollar recalled]

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle.

The product is used as a pain reliever/fever reducer and is packaged in ½ oz. and 1 oz. bottles. This voluntarily recall includes the six (6) lots listed below:

Lot No.: 4718 NDC: 59779-925-23  EXPIRATION: 12/19 COMPANY: CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle | CVS Pharmacy

Lot No.: 00717005A  NDC: 49035-125-24 EXPIRATION: 02/19 COMPANY: Equate: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle |  Wal-Mart Stores Inc.

Lot No.: 00717006A  NDC: 59779-925-24

50428-1252-4: 02/19. CVS Health: Infants' Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle | CVS Pharmacy

00717009A: (Previously announced)  49035-125-23. 02/19. Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle |Wal-Mart Stores Inc

00717015A: (Previously announced)  49035-125-23. 04/19. Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | Wal-Mart Stores Inc

00717024A: (Previously announced) 49035-125-23. 08/19. Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle |Wal-Mart Stores Inc

59779-925-23: CVS Health: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | CVS Pharmacy

55319-250-23: Family Wellness: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottle | Family Dollar Services Inc.

Tris Pharma, Inc. manufactures Ibuprofen Oral Suspension Drops, USP for a single customer, who markets and distributes the product to retailers. The retailers should stop further distribution of the affected lots, which are being recalled. Tris Pharma, Inc. has notified its customer by urgent recall notice and has arranged for the return of recalled products from retailers and distributors.

Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday during business hours or via email at micc_tris@vigilarebp.com.

Cox Media Group