Medicine recalls
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| The United States: Tris Pharma issues voluntary nationwide recall of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, due to potential higher concentrations of ibuprofen |
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The US Food and Drug Administration (FDA) announces that Tris Pharma, Inc. has voluntarily recalled three (3) lots of Infants’ Ibuprofen Concentrated Oral Suspension, USP (NSAID) 50 mg per 1.25 mL, to the retail level. The recalled lots of the product have been found to potentially have higher concentrations of ibuprofen. The affected products are:
- Equate: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID) 50 mg per 1.25 mL, 0.5 oz. bottle, lot: 00717009A (expiration: 02/19), 00717015A (expiration: 04/2019), 00717024A (expiration: 08/19)
- CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID) 50 mg per 1.25 mL, 0.5 oz. bottle, lot: 00717024A (expiration: 08/19)
- Family Wellness: Infants’ Ibuprofen Concentrated Oral Suspension USP (NSAID) 50 mg per 1.25 mL, 0.5 oz. bottle, lot: 00717024A (expiration: 08/19)
There is a remote possibility that infants, who may be more susceptible to a higher potency level of drug, and therefore may be more vulnerable to permanent NSAID-associated renal injury. 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. To date, Tris Pharma, Inc. has not received any reports of adverse events related to the lots of product that are the subject of this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm627780.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Friday, Dec 7, 2018
Issued at HKT 15:00
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