The US Food and Drug Administration (FDA) has issued an announcement about a nationwide recall of nearly 90,000 bottles of children's ibuprofen due to "foreign substance" complaints.
As per a report, around 89,592 bottles of Strides Pharma's Children's Ibuprofen Oral Suspension are being removed from shelves due to the "presence of foreign substance".
About affected drug:
Strides Pharma's 100 mg of Children's Ibuprofen Oral Suspension, USP, 100 mg per 5 mL, sold in 120 mL, bottles were manufactured for Taro Pharmaceuticals USA, Inc., before being distributed across the nation.
The impacted children's ibuprofen has lot numbers 7261973A and 7261974A, with an expiration date of January 31, 2027.
Reason for the recall:
According to the FDA, the products were removed following complaints about "a gel-like mass and black particles" in the medicine.
The recall was initiated on March 2, and the FDA labelled it as Class II, which is described as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote".
