Methylprednisolone dose packs recalled over misoriented blister foil dosing information
Greenstone is recalling 3,456 cartons of methylprednisolone tablets Dosepak, 4 mg, because the blister foil was applied in the wrong orientation, giving incorrect dosing information.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: misoriented blister foil gives incorrect dosing information for a tapering steroid pack, and no injuries are reported.
Plain-English summary
Methylprednisolone Tablets, USP Dosepak, 4 mg, one blister card per carton containing 21 tablets, Rx only, under NDC 59762-4440-2, distributed by Greenstone LLC of Peapack, New Jersey, are being recalled.
The reason given in the enforcement record is a labeling issue: incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
The record lists 3,456 cartons from lot LG7675, expiry November 2026. Distribution was nationwide within the United States. The FDA has classified the action as Class II.
A dose pack whose printed directions do not match the tablets beneath them can lead a patient to take the wrong number of tablets on a given day. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific carton is affected and arrange a replacement.
The recalled product
- Product
- METHYLPREDNISOLONE (METHYLPREDNISOLONE)
- Brand
- METHYLPREDNISOLONE
- Manufacturer
- Greenstone Llc
- Category
- Drug — Corticosteroid
- Affected units
- 3,456
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # LG7675
- Exp. Date Nov 2026
UPCs (3)
- 0359762005014
- 0359762005113
- 0359762444035
Distribution
Distributed nationwide across the United States.
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