FDA-Drug2016-10-12Class IIIPACKAGING DEFECT
Varithena administration pack recalled for incorrect syringe type
OTHERNationwide distribution
Do not use Varithena administration pack
Biocompatibles U.K., Ltd. distributed Varithena administration packs containing an incorrect type of syringe. This defective delivery system could affect proper administration of the medication. The recall affects specific lot numbers with expiration dates in November 2016.
- Check if you have a Varithena administration pack with lot numbers 476670, 476669, 476659, or 475250 (expiration 11/16)
- Do not use the affected pack
- Contact your healthcare provider or pharmacy for a replacement pack
- Return the defective pack to your pharmacy
Hazard
Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack
Sold states
Distributed nationwide
Affected count
3,254 administration packs
Manufactured in
Bortoli House, Weydon Lane; Old Farnham Lane, Farnham, N/A, United Kingdom
Products
Varithena (polidocanol injectable foam) Administration Pack For Use With Varithena, Rx only, Distributed by Biocompatibles, Inc. Oxford, CT 06478, NDC 60635-123-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0001-2017Don't want to check this manually?
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