Placebo for Prednisolone Acetate 1% recall: Sterility Concern
Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
Why was Placebo for Prednisolone Acetate 1% recalled?
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All unexpired lots; Expirations dates of 10/11/2016 to 01/16/2017
- Product
- Placebo for Prednisolone Acetate 1%, Oph Suspension, 10 mL Dropper Bottle, Compounded by Leiter's Compounding, San Jose, CA
- Recalling firm
- Leiter's Compounding
- Quantity
- 76,315 total units, all products
- Distribution
- Nationwide
- Recall date
- October 19, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)