Reported Oct 16, 2019 · Terminated

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured…

Morton Grove Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Morton Grove Pharmaceuticals, Inc. · 6451 Main St · Morton Grove, IL · 60053-2633

Is this the product you have?

  • Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
Lot codes and dates
    • Lot #: US1450
    • Exp 10/31/19
    • US1570
    • Exp 12/31/19
    • UT1018
    • Exp 1/31/19
    • UT1173
    • Exp 6/30/20
    • UT1348
    • UT1354
    • Exp 8/31/20
Amount recalled
196,408 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 24, 2022 · Data as of Sep 19, 5:02 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.