Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: PrednisoLONE Orally Disintegrating Tablets Recalled for Manufacturing Deviations

Agency Publication Date: May 22, 2018

Summary

Mylan Pharmaceuticals Inc. is recalling approximately 21,084 bottles of PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (10 mg, 15 mg, and 30 mg) due to deviations from Current Good Manufacturing Practice (CGMP) standards. This recall affects 48-count prescription bottles distributed to wholesalers across the United States and Puerto Rico. The tablets were found to have manufacturing issues that could potentially impact the quality or consistency of the medication.

Risk

The deviations from standard manufacturing protocols mean the quality, strength, or purity of the medication cannot be guaranteed, which may lead to ineffective treatment or unexpected side effects for patients depending on the drug to manage inflammatory conditions.

What You Should Do

Check your prescription bottle for PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets in 10 mg (NDC 00378-4710-22), 15 mg (NDC 00378-4715-22), or 30 mg (NDC 00378-4730-22) strengths.
For 10 mg tablets, check for lot numbers 3081542, 3081543, 3081544, 3082235 (all Exp. 08/18), 3085903 (Exp. 12/18), 3088974, or 3090445 (both Exp. 06/19).
For 15 mg tablets, check for lot numbers 3082509 (Exp. 08/18) or 3085901 (Exp. 12/18).
For 30 mg tablets, check for lot numbers 3082921 (Exp. 12/18) or 3088975 (Exp. 06/19).
Contact your healthcare provider or pharmacist immediately for guidance if you are using medication from an affected lot; do not stop taking prescribed medication without consulting a professional.
Return any unused product to the pharmacy or place of purchase for a refund and contact Mylan Pharmaceuticals regarding any further instructions.
For more information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall return/refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (10 mg, 48-count bottle)

Model:

NDC 00378-4710-22

Recall #: D-0829-2018

Lot Numbers:

3081542 (Exp. 08/18)

3081543 (Exp. 08/18)

3081544 (Exp. 08/18)

3082235 (Exp. 08/18)

3085903 (Exp. 12/18)

3088974 (Exp. 06/19)

3090445 (Exp. 06/19)

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (15 mg, 48-count bottle)

Model:

NDC 00378-4715-22

Recall #: D-0830-2018

Lot Numbers:

3082509 (Exp. 08/18)

3085901 (Exp. 12/18)

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (30 mg, 48-count bottle)

Model:

NDC 00378-4730-22

Recall #: D-0831-2018

Lot Numbers:

3082921 (Exp. 12/18)

3088975 (Exp. 06/19)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80006

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Sold By: wholesalers

Manufactured In: United States

Units Affected: 3 products (7,334 48-count bottles; 9,906 48-count bottles; 3,844 48-count bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your prescription bottle for PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets in 10 mg (NDC 00378-4710-22), 15 mg (NDC 00378-4715-22), or 30 mg (NDC 00378-4730-22) strengths.

For 10 mg tablets, check for lot numbers 3081542, 3081543, 3081544, 3082235 (all Exp. 08/18), 3085903 (Exp. 12/18), 3088974, or 3090445 (both Exp. 06/19).

For 15 mg tablets, check for lot numbers 3082509 (Exp. 08/18) or 3085901 (Exp. 12/18).

For 30 mg tablets, check for lot numbers 3082921 (Exp. 12/18) or 3088975 (Exp. 06/19).

Contact your healthcare provider or pharmacist immediately for guidance if you are using medication from an affected lot; do not stop taking prescribed medication without consulting a professional.

Return any unused product to the pharmacy or place of purchase for a refund and contact Mylan Pharmaceuticals regarding any further instructions.

For more information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (10 mg, 48-count bottle)

Model:

NDC 00378-4710-22

Recall #: D-0829-2018

Lot Numbers:

3081542 (Exp. 08/18)

3081543 (Exp. 08/18)

3081544 (Exp. 08/18)

3082235 (Exp. 08/18)

3085903 (Exp. 12/18)

3088974 (Exp. 06/19)

3090445 (Exp. 06/19)

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (15 mg, 48-count bottle)

Model:

NDC 00378-4715-22

Recall #: D-0830-2018

Lot Numbers:

3082509 (Exp. 08/18)

3085901 (Exp. 12/18)

Product: PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets (30 mg, 48-count bottle)

Model:

NDC 00378-4730-22

Recall #: D-0831-2018

Lot Numbers:

3082921 (Exp. 12/18)

3088975 (Exp. 06/19)