The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1259-2014·Announced 2014-05-07

John W Hollis Recalls Polidocanol 1% Solution Due to Incorrect Expiration Date

John W Hollis Inc is recalling 2 vials of Polidocanol 1% Solution because the expiration date on the vial is earlier than the date listed on the label.

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 recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The hazard is a minor labeling error regarding the expiration date.

Plain-English summary

John W Hollis Inc is recalling 2 vials of Polidocanol 1% Solution, 50 mL Vial, Rx Only, Not for Resale. The product was distributed in Missouri, Tennessee, Mississippi, and Wisconsin. The specific lot number is 565:27, and the expiration date is 5/31/14.

The recall was initiated due to a labeling error where the expiration date is earlier than the date listed on the vial. This discrepancy could lead to the use of expired medication.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Polidocanol 1% 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 — Pharmacy Compounded
Hazard
Affected units
2

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 #: 565:27
  • Expiry: 5/31/14

Distribution

Distributed in 4 states:

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.

See all 4 products in this recall →

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