Some units have higher levels of Ibuprofen concentration.
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of ConsumerAffairs
January 31, 2019Clik here to view.
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Tris Pharma is expanding its earlier recall of Ibuprofen Oral Suspension Drops by adding three additional lots.
Some units from these batches have been found to have higher levels of Ibuprofen concentration.
No serious adverse events have been reported to date.
The following six lots of the product, used as a pain reliever/fever reducer and packaged in -oz., and 1-oz., bottles, are being recalled:
| 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. |
What to do
Consumers with questions regarding this recall may contact Tris customer service at (732) 940-0358, Monday through Friday, 8:00 AM 5:00 PM (PT) or by email at micc_tris@vigilarebp.com.
