Strides Pharma Recalls Children’s Ibuprofen Due to Contamination
Strides Pharma, an Indian pharmaceutical company, has issued a nationwide recall of nearly 90,000 bottles of children’s ibuprofen. This decision follows reports of contamination within the product, prompting the Food and Drug Administration (FDA) to elevate the recall status to Class II.
Details of the Recall
The recall affects 89,592 bottles of Children’s Ibuprofen Oral Suspension, USP. This medication was manufactured for Taro Pharmaceuticals USA, Inc. and widely distributed across the United States.
Affected Product Information
- Volume: 4-fluid-ounce (120 mL) bottles
- Concentration: 100 mg per 5 mL
- Lot Numbers: 7261973A and 7261974A
- Expiration Date: January 31, 2027
Reports revealed the presence of a “gel-like mass and black particles” in the affected ibuprofen, which triggered the recall. While the FDA’s Class II designation indicates that while there may be some temporary health risks, the chances of serious long-term harm remain low.
Health Precautions
No injuries or illnesses have been reported related to the recalled ibuprofen. However, parents and caregivers are strongly advised to examine their medicine cabinets for affected bottles. It is recommended to discontinue use immediately if any bottles match the lot numbers listed above.
Consumers should reach out to their place of purchase or directly to Strides Pharma for guidance on refunds or replacements. The safety of children remains a priority, and vigilance in checking medications is essential.
