Greenstone LLC Recalls Methylprednisolone Dosepak Tablets Due to Dosing Labeling Error

What Happened

Greenstone LLC has initiated a voluntary recall of one lot of Methylprednisolone tablets, USP Dosepak, 4 mg. The recall was prompted by a labeling error involving the incorrect orientation of the blister foil applied to the blister cavities. This manufacturing defect results in incorrect dosing information when a patient follows the directions printed on the foil.

Which Products Are Affected

The recall affects 3,456 cartons of the following product distributed nationwide within the United States:

• Product Name: Methylprednisolone tablets, USP Dosepak, 4 mg
• Configuration: 1 Blister Card per Carton containing 21 Tablets
• NDC (National Drug Code): 59762-4440-2
• Lot Number: LG7675
• Expiration Date: Nov 2026
• UPC: 0359762444035
• Manufacturer: Mylan Pharmaceuticals Inc.
• Distributor: Greenstone LLC, Peapack, NJ

What You Should Do

Consumers and healthcare providers should immediately check their supply for Lot # LG7675. If you have the affected product, you should contact your physician or pharmacist regarding the correct dosing schedule or to obtain a replacement. Patients should not follow the dosing instructions printed on the blister foil of the affected lot. For further information, consumers may contact the recalling firm, Greenstone LLC, based in Peapack, New Jersey.

Why This Matters

This recall is significant because the incorrect orientation of the foil leads to inaccurate dosing instructions. Following incorrect directions for a prescription corticosteroid could result in a patient receiving the wrong dose, potentially leading to ineffective treatment or adverse health consequences.

Source

Information provided by the U.S. Food and Drug Administration (FDA). Recall Number: D-0299-2026.