Drug product
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
D-1388-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 mL
- Official record key
drug-enforcement:D-1388-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: Lot 563.61, use by 05/31/14; Lot 2616, Use by 3/31/15
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility