Why it was recalled
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
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
Lot numbers, UPCs & expiration codes
Lot # 476670,476669,476659,475250; Exp 11/16
Where it was sold
Distributed nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0001-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 7, 2016
- FDA report date
- Oct 12, 2016
- Quantity
- 3,254 administration packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Biocompatibles U.K., Ltd.
Original FDA data
Every field from FDA enforcement report D-0001-2017, exactly as published.
Show all FDA fields
- City
- Farnham
- Status
- Terminated
- Country
- United Kingdom
- Event ID
- 75253
- Address
- Bortoli House
- Address (line 2)
- Weydon Lane; Old Farnham Lane
- Code information
- Lot # 476670,476669,476659,475250; Exp 11/16
- Report date
- Oct 12, 2016
- Product type
- Drugs
- Recall number
- D-0001-2017
- Classification
- Class III
- Recalling firm
- Biocompatibles U.K., Ltd.
- Product quantity
- 3,254 administration packs
- Termination date
- Feb 27, 2017
- Reason for recall
- Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed nationwide
- Recall initiation date
- Sep 7, 2016
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2016