Varithena Administration Packs Recalled Due to Incorrect Syringe Type
Biocompatibles is recalling Varithena administration packs because they contain the incorrect type of syringe. The recall covers 3,254 packs distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or packaging issues.
Plain-English summary
Biocompatibles U.K., Ltd. is recalling 3,254 administration packs of Varithena (polidocanol injectable foam) for use with Varithena. The recall is due to a defective delivery system where an incorrect type of syringe was found in the commercially distributed packs. The affected products are prescription-only and were distributed nationwide.
The specific lots involved are #476670, #476669, #476659, and #475250, all with an expiration date of 11/16. The NDC for the recalled product is 60635-123-01. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- VARITHENA (POLIDOCANOL)
- Brand
- VARITHENA
- Manufacturer
- Biocompatibles U.K., Ltd.
- Category
- Drug — Injectable Foam
- Affected units
- 3,254
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lot # 476670
- 476669
- 476659
- 475250
- Exp 11/16
Distribution
Distributed nationwide across the United States.
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