Medications & Supplements/Prescription Drugs

Morton Grove Pharmaceuticals, Inc.: Prednisolone Sodium Phosphate Oral Solution Recalled for Defective Foil Seals

Agency Publication Date: August 3, 2018

Summary

Morton Grove Pharmaceuticals, Inc. has recalled 38,280 bottles of Prednisolone Sodium Phosphate Oral Solution (15 mg/5 mL) because the tamper-evident foil seals on the 8 fl oz (237 mL) bottles may not be completely intact. This prescription medication is used to treat various inflammatory and allergic conditions. Consumers should check their medicine cabinets for the specific lot US1259 of this oral liquid medication, which was distributed nationwide across the United States.

Risk

A compromised or incomplete tamper-evident seal may allow the medication to be exposed to air or external contaminants, which can affect the product's integrity and safety. If the seal is not intact, there is no way to guarantee that the medication has not been tampered with or contaminated during distribution.

What You Should Do

Check your prescription bottle to see if it is Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL in an 8 fl oz (237 mL) size with NDC 60432-212-08.
Verify the lot number on the bottle label; this recall specifically affects Lot US1259.
Inspect the tamper-evident foil seal underneath the cap to ensure it is fully intact and has not been breached.
Contact your healthcare provider or pharmacist immediately for guidance if you have this medication, and return any unused product to the pharmacy for a refund.
Contact Morton Grove Pharmaceuticals, Inc. at their Morton Grove, Illinois facility for further instructions regarding this recall.
For additional questions 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

Healthcare consultation and pharmacy return

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 (8 fl oz / 237 mL)

Model:

NDC 60432-212-08

Recall #: D-1042-2018

Lot Numbers:

US1259

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80386

Status: Resolved

Manufacturer: Morton Grove Pharmaceuticals, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 38,280 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 to see if it is Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL in an 8 fl oz (237 mL) size with NDC 60432-212-08.

Verify the lot number on the bottle label; this recall specifically affects Lot US1259.

Inspect the tamper-evident foil seal underneath the cap to ensure it is fully intact and has not been breached.

Contact your healthcare provider or pharmacist immediately for guidance if you have this medication, and return any unused product to the pharmacy for a refund.

Contact Morton Grove Pharmaceuticals, Inc. at their Morton Grove, Illinois facility for further instructions regarding this recall.

For additional questions 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.