John W Hollis Inc Recalls Polidocanol 3% Solution Due to Particulate Matter
John W Hollis Inc is recalling 3 vials of Polidocanol 3% Solution due to the presence of particulate matter. The product was distributed in Missouri, Tennessee, Mississippi, and Wisconsin.
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 agency classification is FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences are classified as Severe (Score 4), particularly when the agency's own classification is Class II and the defect involves physical contamination (particulate matter) in an injectable solution.
Plain-English summary
John W Hollis Inc is recalling 3 vials of Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. The recall was initiated because of the presence of particulate matter in the product. The specific lot number is 641:07, and the expiration date is 8/11/14.
The affected product was distributed in Missouri, Tennessee, Mississippi, and Wisconsin. The product is prescription-only and was not intended for resale. The manufacturer is John W Hollis Inc, located at John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
Consumers who have this specific product should contact their healthcare provider or the recalling firm for instructions on how to proceed. The U.S. Food and Drug Administration has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Polidocanol 3% Solution, 50 mL Vial, Rx Only, Not for Resale. John Hollis Pharmacy, 110 20th Avenue N, Nashville, TN 37203.
- Manufacturer
- John W Hollis Inc
- Category
- Drug — Injectable Solution
- Hazard
- Affected units
- 3
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 #: 641:07
- Expiry: 8/11/14
Distribution
Part of a larger recall action
This product is one of 4 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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