Product: Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234
Reason for recall: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recall initiated: 20140512
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated