February 5, 2019 — Tris Pharma Inc. has expanded a recall for infant ibuprofen because the bottles may contain higher concentrations of the drug than is listed on the label.

The recalled products were sold at CVS, Walmart, and Family Dollar stores under brand-names such as CVS Health®, Walmart Equate®, and Family Wellness®.

The company announced a previous recall on December 5, 2018, warning that infants are more likely to experience an accidental overdose — including permanent kidney damage.

Other serious side effects may include:

“Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects.”

This voluntarily recall includes the six (6) lots listed below:

Lot No.NDCEXPIRATIONDESCRIPTIONCOMPANY
471859779-925-2312/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 0.5 oz. bottleCVS Pharmacy
00717005A49035-125-2402/19Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottleWal-Mart Stores Inc.
00717006A59779-925-24

 

(Labeled as: 50428-1252-4)

02/19CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP, 50 mg per 1.25 mL, in 1.0 oz. bottleCVS Pharmacy
00717009A
(Previously announced)
49035-125-2302/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
00717015A
(Previously announced)
49035-125-2304/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
00717024A
(Previously announced)
49035-125-2308/19Equate: Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 ml, in 0.5 oz. bottleWal-Mart Stores Inc
59779-925-23CVS Health: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
CVS Pharmacy
55319-250-23Family Wellness: Ibuprofen Oral Suspension Drops,
USP, 50 mg per 1.25 ml, in 0.5 oz. bottle
Family Dollar Services Inc.

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.

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