D-1388-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 25, 2014
- Initiation Date
- May 12, 2014
- Termination Date
- July 2, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 mL
Product Description
Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist 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 Pattern
Nationwide
Code Information
Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15