Recalls / Class III
Class IIID-0001-2017
Product
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
- Brand name
- Varithena
- Generic name
- Polidocanol
- NDCs
- 60635-118, 60635-107, 60635-111, 60635-133, 60635-123
- FDA application
- NDA205098
- Affected lot / code info
- Lot # 476670,476669,476659,475250; Exp 11/16
Why it was recalled
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Recalling firm
- Firm
- Biocompatibles U.K., Ltd.
- Manufacturer
- Biocompatibles, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Bortoli House, Weydon Lane; Old Farnham Lane, Farnham, N/A N/A, United Kingdom
Distribution
- Quantity
- 3,254 administration packs
- Distribution pattern
- Distributed nationwide
Timeline
- Recall initiated
- 2016-09-07
- FDA classified
- 2016-10-03
- Posted by FDA
- 2016-10-12
- Terminated
- 2017-02-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0001-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.