John W Hollis Recalls Polidocanol Injection Due to Sterility Concerns
John W Hollis Inc is recalling Polidocanol 0.5% Solution for Injection because the products lack assurance of sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death from infection.
Plain-English summary
John W Hollis Inc is recalling specific lots of Polidocanol 0.5% Solution for Injection. The recall is due to a lack of assurance of sterility in the compounded aseptically filled injectable products.
The affected products are 50 mL vials containing Polidocanol (Laureth 9) 5mg. The recall covers Lot 563.61 with a use-by date of 05/31/14 and Lot 2616 with a use-by date of 3/31/15. The total quantity involved is 300 mL.
These products were distributed nationwide. Consumers and healthcare providers should stop using the affected lots and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL, JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable Solution
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 (4)
- Lot 563.61
- use by 05/31/14
- Lot 2616
- Use by 3/31/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 19 recalled by John W Hollis Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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