Polidocanol 5% Solution for Injection recall: Sterility Concern
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol…
Why was Polidocanol 5% Solution for Injection recalled?
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
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?
Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14
- Product
- Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol…
- Recalling firm
- John W Hollis Inc
- Quantity
- 550 mL
- Distribution
- Nationwide
- Recall date
- June 25, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)