Food recall

Tarry Medical Products, Inc. recall: Product comes in a plastic bag which is labeled as follows

Tarry Medical Products, Inc., of Danbury, CT, recalled Product comes in a plastic bag which is labeled as follows. The FDA's reason: “Microorganism found inside vial.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on September 20, 2018, and the FDA first listed it in its Enforcement Report of October 24, 2018. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

See FDA's words below

Status

Terminated

Closed November 29, 2018

The recall

Company
Tarry Medical Products, Inc. (Danbury, CT)
Reason, in FDA's words
“Microorganism found inside vial.”
Where it was sold
Direct to PA, WI, OH, GA, NE, CA
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
81082

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-0058-2019 Class II

    Product comes in a plastic bag which is labeled as follows: DandleLION MEDICAL DandleLION KISSES ORAL USE ONLY SINGLE PATIENT USE SINGLE APPLICATION 24% ORGANIC SUCROSE, D-12442 2mL; The Product Case Labeling is as follows: DandleLION MEDICAL D 12242 C384 DandleLION KISSES (2ML) 24% ORGANIC SUCROSE SOLUTION ORANGE VIAL QTY - 384

    Codes: Lot/Unit Numbers: DUP Manufacturer's Batch Code: F17272

    Quantity: 46 cases (17664 vials)

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of October 24, 2018.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.