Food recall

The Harvard Drug Group, LLC recall: Thera Tablets with Beta Carotene Dietary Supplement

The Harvard Drug Group, LLC, of Livonia, MI, recalled Thera Tablets with Beta Carotene Dietary Supplement. The FDA's reason: “The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a...” The FDA classified it Class III: it is unlikely to cause harm. The company began the recall voluntarily on December 31, 2014, and the FDA first listed it in its Enforcement Report of February 4, 2015. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class III

It is unlikely to cause harm

Why

Labeling, packaging or manufacturing problems

Status

Terminated

Closed March 9, 2016

The recall

Company
The Harvard Drug Group, LLC (Livonia, MI)
Reason, in FDA's words
“The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint and found that six 2 x 5 blister cards inside a carton was missing some or all of the product information on the back of the blister card.”
Where it was sold
Domestic: AL, AZ, CA, CO, CT, FL, GA, IL, KY, MA, MI, MO, MS, NC, NE NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI, WV. Foreign: None Foreign:
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
70171

The product recalled

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

  • F-0925-2015 Class III

    Thera Tablets with Beta Carotene Dietary Supplement

    Codes: Lot Number: M-00953 Expiration Date: 06-2015, UPC Code: 3 09040 53961 8

    Quantity: 5,700 unit doses 10 x 10 cartons

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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 February 4, 2015.

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.