CLASS II Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report
Placebo for Prednisolone Acetate 1%, Oph Suspension Dropper recalled
Leiter's Compounding is recalling Placebo for Prednisolone Acetate 1%, Oph Suspension Dropper, Compounded by Leiter's, distributed nationwide in the US. The recall was initiated on 20 Sep 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0017-2017
- FDA event ID
- 75230
- Recalling firm
- Leiter's Compounding, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Sep 2016
- FDA classified
- 12 Oct 2016
- Reported
- 19 Oct 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Compounded Drugs
Timeline
| 20 Sep 2016 | Recall initiated by company | |
| 12 Oct 2016 | Classified by FDA | +22 days |
| 19 Oct 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Which lots are affected?
All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 75230This product is part of a recall event; the main page for the event is Cyclopentolate HCl 1% - Tropicamide recalled by Leiter's Compounding.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cyclopentolate HCl 1% - Tropicamide recalled by Leiter's Compounding | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Atropine Sulfate 0.01% in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Brilliant Blue G 0.025% in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recalled | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Vancomycin 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Lidocaine HCl 1% - Phenylephrine HCl recalled by Leiter's Compounding | Leiter's Compounding | Sterility | Nationwide | |
| CLASS II | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection recalled | Leiter's Compounding | Sterility | Nationwide |
More recalls from Leiter's Compounding
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mitomycin 0.02% (0.2 mg/mL) in Sterile Water for Injection recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Lidocaine HCl 1% - Phenylephrine HCl recalled by Leiter's Compounding | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Vancomycin 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |
| Drug | CLASS II | Moxifloxacin 1 mg/mL in Sterile Balanced Salt Solution recalled | Leiter's Compounding | Sterility | Nationwide |