FDAFDA · Food and drugs·Recall number D-1391-2014
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
Published June 25, 2014 · Recall initiated: May 12, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- John W Hollis Inc
- Distributor
- Nationwide
- Lot
- Lot 1076, use by 08/28/14; Lot 2410, use by 09/13/14; Lot 2746, use by 10/06/14
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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