Tris Pharma, Inc. has announced that it is voluntarily recalling three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension. The recalled lots of the product may have higher concentrations of ibuprofen than the intended dosage.
There is a remote risk to infants. Infants may be more susceptible to a higher dosage of Ibuprofen, which could cause permanent NSAID-associated renal injury. Other side effects may include nausea, vomiting, epigastric pain, or diarrhea.
Infant Ibuprophen is used as a pain reliever/fever reducer. The recalled product was packaged in 0.5 oz. bottles and the affected lots are listed below:
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. |
Consumers with questions regarding this recall can contact Tris Customer Service at 732-940-0358 (Monday through Friday, 8:00am ET- 5:00pm PT) or via email at Customer Service Email . 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.
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