Class II · Moderate risk
prednisoLONE Acetate Ophthalmic Suspension
Presence of Foreign Substance
Placebo for Prednisolone Acetate 1%
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Drug: Prednisolone
- Recalling firm
- Leiter's Compounding
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0017-2017 · 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 Leiter's Compounding
All 2016 recalls
Class II · Moderate risk
Vancomycin 10 mg/mL in 0.9% Sodium Chloride
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Mitomycin 0.02%
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Class II · Moderate risk
Lidocaine HCl 1% - Phenylephrine HCl 1.5% in Sterile Water for Injection
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
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