Drug product
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
D-0001-2017
Product summary
- Event
- Event 75253
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,254 administration packs
- Official record key
drug-enforcement:D-0001-2017
Official wording
Reason: Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Code information: Lot # 476670,476669,476659,475250; Exp 11/16
Distribution pattern: Distributed nationwide
Derived failure modes
-
Unknown
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack