John W Hollis Recalls Polidocanol 1% Injection Due to Sterility Concerns
John W Hollis Inc. is recalling Lot 2868 of Polidocanol 1% Solution for Injection because the company cannot ensure the product is sterile.
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, which corresponds to a Severe severity score under the rubric for significant injury risks or hospitalization reports.
Plain-English summary
John W Hollis Inc. is recalling Lot 2868 of Polidocanol 1% Solution for Injection, 50 mL vials. The recall is due to a lack of assurance of sterility in the compounded aseptically filled injectable products.
The affected product is distributed nationwide. The specific lot number is 2868, with a best used by date of 3/15/15. The product contains Polidocanol (Laureth 9) 10 mg per mL, along with Sterile Water for Injection, Ethyl Alcohol, and Anhydrous Chlorobutanol.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm for further instructions.
The recalled product
- Product
- Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth 9) 10 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL, JOHN HOLLIS Pharmacist, Inc. 110 B2 Avenue N, Nashville, TN 37203, 615-327-3234
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable Solution
- Hazard
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 (2)
- Lot 2868
- Best used by 3/15/15
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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