The company has added three lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail level. In rare cases, infants exposed to too much ibuprofen may be vulnerable to permanent kidney damage.
Some products from these batches were found to contain higher levels of Ibuprofen concentration.
The recalled products sold at Walmart had expiration dates of February 2019, April 2019 and August 2019, while those made for CVS and Family Dollar expire in August 2019 and December 2019. Studies have shown that safety issues or toxicity are generally accepted to be a concern in infants at doses in excess of 700% of the recommended dose.
"Adverse effects that may be experienced are nausea, vomiting, epigastric pain, or more rarely, diarrhea", according to Tris Pharma in November. Tinnitus, headache and gastrointestinal bleeding are also possible adverse effects, the recall says.
The products were packaged in 0.5 and 1 ounce bottles and are used to reduce fever and pain.
The drops are sold under CVS' house brand and the Equate brand, which is sold at Walmart. Recalled medicine will have lot numbers 00717005A, 00717009A, 00717015A and 00717024A.
Consumers have been asked to throw the recalled medications away, while retailers have been advised to stop distribution of the affected lots.
People with questions regarding this recall may contact Tris Customer Service by 732-940-0358 (Monday through Friday, 8:00 AM ET- 5:00 PM PT) or via email at email@example.com.
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