FDA (Drugs) recall action 67812
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Presence of Particulate Matter
Labeling: Incorrect Expiration Date; Expiration date is earlier than listed on vial.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
John W Hollis Inc is recalling specific vials of Papaverine, Phentolamine, and Atropine solution due to an incorrect expiration date on the label.
John W Hollis Inc is recalling 7 vials of Phosphatidylcholine Solution for Injection because the expiration date on the label is earlier than the date listed on the vial.
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.