Mylan Pharmaceuticals PrednisoLONE Sodium Phosphate Orally Recall

Why it was recalled

CGMP Deviations

Product description

PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22

Lot numbers, UPCs & expiration codes

Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18

Where it was sold

Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0830-2018
Classification: Class II
Status: Terminated
Recall initiated: Apr 30, 2018
FDA report date: May 30, 2018
Quantity: 9,906 48-count bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Mylan Pharmaceuticals Inc.

Original FDA data

Every field from FDA enforcement report D-0830-2018, exactly as published.

Show all FDA fields

City: Morgantown
State: WV
Status: Terminated
Country: United States
Event ID: 80006
Address: 781 Chestnut Ridge Rd
Code information: Lot #: 3082509; Exp. 08/18 3085901; Exp. 12/18
Postal code: 26505-2730
Report date: May 30, 2018
Product type: Drugs
Recall number: D-0830-2018
Classification: Class II
Recalling firm: Mylan Pharmaceuticals Inc.
Product quantity: 9,906 48-count bottles
Termination date: Feb 14, 2019
Reason for recall: CGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
Distribution pattern: Recalling firm distributed product to wholesalers throughout the United States, including Puerto Rico.
Recall initiation date: Apr 30, 2018
Initial firm notification: Letter
Center classification date: May 22, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0830-2018, published May 30, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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