FDA recall D-1391-2014

Product

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

Reason for recall

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-05-12

Report date

2014-06-25

Termination date

2014-07-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Nashville, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1391-2014