Recalls / Class II
Class IID-1406-2014
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
- Affected lot / code info
- Lot 2868, Best used by 3/15/15
Why it was recalled
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Recalling firm
- Firm
- John W Hollis Inc
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 110 20th Ave N, N/A, Nashville, Tennessee 37203-2315
Distribution
- Quantity
- 100 mL
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-05-12
- FDA classified
- 2014-06-18
- Posted by FDA
- 2014-06-25
- Terminated
- 2014-07-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1406-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.