John W Hollis Recalls Polidocanol 5% Injection Due to Sterility Concerns
John W Hollis Inc is recalling Polidocanol 5% 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 rating under the rubric. The hazard involves a lack of sterility assurance in an injectable product, posing a significant risk of infection.
Plain-English summary
John W Hollis Inc is voluntarily recalling specific lots of Polidocanol 5% Solution for Injection. The recall is being conducted because the company lacks assurance of sterility for these aseptically filled injectable products. The affected product is a 50 mL vial containing Polidocanol (Laureth 9) 50 mg per mL, along with Sterile Water for Injection, Ethyl Alcohol, and Anhydrous Chlorobutanol.
The recall covers three specific lots: Lot 1076 (use by 08/28/14), Lot 2410 (use by 09/13/14), and Lot 2746 (use by 10/06/14). The total quantity involved is 550 mL. The product was distributed nationwide.
Healthcare providers and patients should stop using the affected lots immediately. Users should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.
The recalled product
- Product
- Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth 9) 50 mg, also contains Sterile Water for Injection, Ethyl Alcohol, Anhydrous Chlorobutanol, 50 mL Vial, JOHN HOLLIS Pharmacist Inc, Inc. 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable
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 (6)
- Lot 1076
- use by 08/28/14
- Lot 2410
- use by 09/13/14
- Lot 2746
- use by 10/06/14
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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