February 5, 2019 — Tris Pharma Inc. has announced an expanded recall for bottles of infant ibuprofen that contain higher amounts of ibuprofen than what is listed on the label.
The recalled baby ibuprofen was sold under brand-names such as CVS Health®, Walmart Equate®, and Family Wellness® at CVS, Walmart, and Family Dollar stores.
Tris Pharma previously recalled a limited amount of infant ibuprofen on December 5, 2018.
The manufacturer has warned that infants are more susceptible to serious injuries from ibuprofen overdoses, including permanent kidney injury. Other serious side effects 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. | NDC | EXPIRATION | DESCRIPTION | COMPANY |
|---|---|---|---|---|
| 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. |
For more information, consumers with questions can 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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