Recalls / Class II
Class IID-0017-2017
Product
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
- Affected lot / code info
- All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017
Why it was recalled
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Recalling firm
- Firm
- Leiter's Compounding
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 17 Great Oaks Blvd, N/A, San Jose, California 95119-1359
Distribution
- Quantity
- 76,315 total units, all products
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-09-20
- FDA classified
- 2016-10-12
- Posted by FDA
- 2016-10-19
- Terminated
- 2017-05-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0017-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.