Tris Pharma, Inc. Infant Ibuprofen liquid sold at Walmart, CVS being recalled

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Tris Pharma, Inc. is expanding its November recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen.

The company is 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.

Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury.

Some units from these six (6) lots have been found to contain Ibuprofen as high as 10% above the specified limit. Studies have shown that safety issues or toxicity is generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.

To date, no serious adverse events have been reported related to this recall.

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:

4718 59779-925-23 12/19 CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottle CVS Pharmacy

00717005A 49035-125-24 02/19 Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottle Wal-Mart Stores Inc.

00717006A 59779-925-24 (Labeled as: 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.

Product pictures can be found by clicking this link. Consumers with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at micc_tris@vigilarebp.com.

Consumers, who may be concerned, should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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