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Recall Observatory FDA recall evidence

Food product

Thera Tablets with Beta Carotene Dietary Supplement

F-0925-2015

December 31, 2014

Class III

Product summary

Firm
The Harvard Drug Group, LLC
Event
Event 70171
Status
Terminated
Classification
Class III
Quantity
5,700 unit doses 10 x 10 cartons
Official record key
food-enforcement:F-0925-2015

Official wording

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 carton was missing some or all of the product information on the back of the blister card.

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

Distribution pattern: 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:

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    missing labeling