The United States Food and Drug Administration (FDA) announced that almost 90,000 bottles of pediatric ibuprofen on sale nationwide have been recalled.
In a compliance report, the federal agency said 89,592 bottles of Strides Pharma children’s ibuprofen oral suspension are being recalled due to the “presence of foreign substances.”
Here’s what you need to know about withdrawal.
Which children’s ibuprofen is affected?
Strides Pharma Children’s Ibuprofen 100 mg Oral Suspension, USP, with 100 mg per 5 mL, sold in 4 fluid ounce (120 mL) bottles, was manufactured for Taro Pharmaceuticals USA, Inc. before being distributed nationwide.
According to the report, the recall was voluntary and was initiated by New Jersey-based Strides Pharma Inc.
(This is the most important habit from the age of 30 to maintain a healthy heart throughout life, according to cardiologists)
The affected children’s ibuprofen has lot numbers 7261973A and 7261974A, with an expiration date of January 31, 2027.
Strides Pharma did not immediately respond to a request for comment.
Why was it withdrawn from the market?
The products were recalled after receiving complaints that described “a gelatinous mass and black particles” in the medication, according to the FDA.
Following complaints, the withdrawal was initiated on March 2, according to the report. The FDA classified the recall as Class II on Monday.
(This is the reason behind the allergies that come with the onset of spring)
A Class II recall involves “a situation in which use of or exposure to a nonconforming product may cause temporary or medically reversible adverse health consequences, or in which the likelihood of serious adverse health consequences is remote,” according to the FDA website.
What to do if you have the product recalled?
People should immediately stop using the recalled product. No additional information on next steps was provided in the report.
