(WPRI) — Parents will want to check their medicine cabinets.
Tris Pharma, Inc. has voluntarily recalled three lots of infants’ ibuprofen concentrated oral suspension because the lots potentially have higher concentrations of ibuprofen than the label says.
The product is used as a pain reliever/fever reducer and was packaged in 0.5 oz. bottles which were sold as store brands for Walmart, CVS Pharmacy and Family Dollar.
NDC |
LOT |
EXPIRATION |
DESCRIPTION |
COMPANY |
49035-125-23 |
00717009A 00717015A 00717024A |
02/19 04/19 08/19 |
Equate: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
Wal-Mart Stores Inc |
59779-925-23 |
00717024A |
08/19 |
CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
CVS Pharmacy |
55319-250-23 |
00717024A |
08/19 |
Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, 0.5 oz. bottle |
Family Dollar Services Inc. |
The company said there is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury.
The company said 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.
Tris Pharma, Inc. said it has not received any reports of adverse events related to the lots of product that are the subject of this recall.
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8: a.m. to 8 p.m.) or via email at Customer Service Email.
The company said consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
