Something you purchased has been recalled. What does that mean?
What happens if something you purchase is recalled? Is it voluntary or mandatory? And what does it mean for you?
Millions of prescription eye drops are being recalled across the country, according to a Food and Drug Administration enforcement report.
More than 2.5 million bottles of prednisolone acetate eye drops have been recalled due to possible foreign substances, according to an FDA enforcement report. The affected eye drops were manufactured by Lupine Pharmaceutical Co., Ltd.
The recall began on June 4, but was recently classified as a Class II recall on June 30, according to the enforcement report. According to the FDA, Class II recalls apply to products that, if used or exposed, may cause temporary or medically reversible adverse health effects.
According to the Mayo Clinic, prednisolone eye drops are used to treat mild to moderate noninfectious eye allergies and inflammation, including chemical burns and burn injuries. This drug is also used to treat eye inflammation caused by certain conditions.
“Prednisolone is a steroid medication used to reduce redness, itching, and swelling caused by eye infections and other conditions,” the Mayo Clinic said on its website, adding that the drug is only available with a doctor’s prescription.
Which eye drop bottles are being recalled?
According to the FDA, the recalled bottles are labeled “Prednisolone Acetate Eye Drops, USP, 1%, Rx Only.” The agency is collecting 5mL, 10mL and 15mL bottles. National drug codes for each bottle size are listed below.
- 5mL (NDC 70748-332-02)
- 10mL (NDC 70748-332-03)
- 15mL(70748-332-04)
This recall affects 2,530,182 bottles of eye drops manufactured by Lupine Limited, Pithampur (MP) 454 775, India. The recall number is D-0655-2026.
According to the FDA, dozens of lot codes and individual bottles were affected by the recall. Please see the enforcement report to see if your prescriptions are affected.
What should I do with recalled eye drops?
The FDA’s enforcement report does not detail remedies for people with affected eye drops. However, the federal agency says individuals should immediately stop using the recalled products. Manufacturers must also notify customers who received affected products about the recall and provide instructions on how to handle the products, according to the FDA.
USA TODAY contacted Lupine Pharmaceuticals on July 9 for information about the recall.
Gabe Hauari is USA TODAY’s national trends news reporter. You can follow him at X @gabehauari Or email Gdhauari@usatodayco.com.
