Polidocanol recall: Sterility Concern
Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL
Why was Polidocanol recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
0.75% Lot L5611 Exp 11/30/13 // 1% Lot b3001 Exp 6/19/13, B5014 Exp 8/14/13, and A5431 Exp 6/4/13 // 3% Lot A5808 Exp 12/31/13 // 10% Lot C5328 Exp 9/3/13
- Product
- Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Quantity
- 6
- Distribution
- Nationwide and PR
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)