Reported Jun 25, 2014 · Terminated
Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for…
John W Hollis Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: John W Hollis Inc · 110 20th Ave N · Nashville, TN · 37203-2315
Is this the product you have?
- Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Lot codes and dates
Lot 1076use by 08/28/14Lot 2410use by 09/13/14Lot 2746use by 10/06/14
- Amount recalled
- 550 mL
This recall covers 19 products
The agency filed one notice per product. You are reading one of them; the other 18 are below.
6 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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