Medications & Supplements/Prescription Drugs

Morton Grove Pharmaceuticals, Inc.: Prednisolone Sodium Phosphate Recalled for Failed Impurity Specifications

Agency Publication Date: October 8, 2019

Summary

Morton Grove Pharmaceuticals, Inc. is recalling approximately 196,408 bottles of Prednisolone Sodium Phosphate Oral Solution (15 mg/5 mL), a prescription medication used to treat various inflammatory and allergic conditions. This recall was initiated because the product failed quality testing specifications for a specific degradation byproduct known as Prednisolone Impurity 14. These 8-ounce bottles were distributed across the United States and Puerto Rico. You should contact your doctor or pharmacist if you have this medication in your home to determine if it is part of the affected batch.

Risk

The presence of impurities or degradation products above the approved limits can potentially affect the safety, potency, and effectiveness of the medication. While no specific injuries have been reported, consuming medication that does not meet chemical specifications may result in unexpected side effects or reduced treatment efficacy.

What You Should Do

Check your prescription bottle label for the product name 'Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL' in 8 fl oz (237 mL) bottles with NDC 60432-212-08.
Verify the lot number and expiration date on the side of the bottle. Affected lots include: US1450 (Exp 10/31/19), US1570 (Exp 12/31/19), UT1018 (Exp 1/31/19), UT1173 (Exp 6/30/20), and UT1348 or UT1354 (Exp 8/31/20).
Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is from one of the affected lots. Do not stop taking a prescribed steroid medication without consulting your doctor first, as sudden discontinuation can be harmful.
Return any unused product from the identified lots to the pharmacy where it was purchased for a refund and further instruction.
Contact Morton Grove Pharmaceuticals at their headquarters in Morton Grove, Illinois, if you have specific questions about this recall.
For additional 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

Refund for unused medication.

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 Oral Solution, 15 mg/5 mL (8 fl oz / 237 mL)

Model:

NDC 60432-212-08

Recall #: D-0130-2020

Lot Numbers:

US1450 (Exp 10/31/19)

US1570 (Exp 12/31/19)

UT1018 (Exp 1/31/19)

UT1173 (Exp 6/30/20)

UT1348 (Exp 8/31/20)

UT1354 (Exp 8/31/20)

Date Ranges: Exp 10/31/19, Exp 12/31/19, Exp 1/31/19, Exp 6/30/20, Exp 8/31/20

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 83858

Status: Resolved

Manufacturer: Morton Grove Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 196,408 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

Risk

What You Should Do

Check your prescription bottle label for the product name 'Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL' in 8 fl oz (237 mL) bottles with NDC 60432-212-08.

Verify the lot number and expiration date on the side of the bottle. Affected lots include: US1450 (Exp 10/31/19), US1570 (Exp 12/31/19), UT1018 (Exp 1/31/19), UT1173 (Exp 6/30/20), and UT1348 or UT1354 (Exp 8/31/20).

Contact your healthcare provider or pharmacist immediately for guidance if you find your medication is from one of the affected lots. Do not stop taking a prescribed steroid medication without consulting your doctor first, as sudden discontinuation can be harmful.

Return any unused product from the identified lots to the pharmacy where it was purchased for a refund and further instruction.

Contact Morton Grove Pharmaceuticals at their headquarters in Morton Grove, Illinois, if you have specific questions about this recall.

For additional 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 Oral Solution, 15 mg/5 mL (8 fl oz / 237 mL)

Model:

NDC 60432-212-08

Recall #: D-0130-2020

Lot Numbers:

US1450 (Exp 10/31/19)

US1570 (Exp 12/31/19)

UT1018 (Exp 1/31/19)

UT1173 (Exp 6/30/20)

UT1348 (Exp 8/31/20)

UT1354 (Exp 8/31/20)

Date Ranges: Exp 10/31/19, Exp 12/31/19, Exp 1/31/19, Exp 6/30/20, Exp 8/31/20