D-0001-2017 Class III Terminated
FDA drug recall D-0001-2017 was initiated by Biocompatibles U.K., Ltd. on September 7, 2016 and is designated Class III. Reason for recall: Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack The recall status is terminated (terminated February 27, 2017). Affected quantity: 3,254 administration packs.
Recall Details
- Product Type
- Drugs
- Report Date
- October 12, 2016
- Initiation Date
- September 7, 2016
- Termination Date
- February 27, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,254 administration packs
Product Description
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Reason for Recall
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Distribution Pattern
Distributed nationwide
Code Information
Lot # 476670,476669,476659,475250; Exp 11/16