Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Prednisolone Sodium Phosphate Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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
Affected NDC
60432-0212-08
Compare with the code on your package — it is the most precise check available.
Drug: Prednisolone
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- NDC code
- 60432-212-08
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0130-2020 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Prednisolone recalls
See all
Class III · Low risk
Pred Mild
Failed Stability Specifications
Class II · Moderate risk
Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension
Lack of Assurance of Sterility
Class II · Moderate risk
Class II · Moderate risk
Prednisolone Oral Solution
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Other recalls by Morton Grove Pharmaceuticals, Inc.
All 2019 recalls
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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