Why it was recalled
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.
Product description
Thera Tablets with Beta Carotene Dietary Supplement
Lot numbers, UPCs & expiration codes
Lot Number: M-00953 Expiration Date: 06-2015, UPC Code: 3 09040 53961 8
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:
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-0925-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Dec 31, 2014
- FDA report date
- Feb 4, 2015
- Quantity
- 5,700 unit doses 10 x 10 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group, LLC
Original FDA data
Every field from FDA enforcement report F-0925-2015, exactly as published.
Show all FDA fields
- City
- Livonia
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 70171
- Address
- 31778 Enterprise Dr
- Code information
- Lot Number: M-00953 Expiration Date: 06-2015, UPC Code: 3 09040 53961 8
- Postal code
- 48150-1960
- Report date
- Feb 4, 2015
- Product type
- Food
- Recall number
- F-0925-2015
- Classification
- Class III
- Recalling firm
- The Harvard Drug Group, LLC
- Product quantity
- 5,700 unit doses 10 x 10 cartons
- Termination date
- Mar 9, 2016
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Thera Tablets with Beta Carotene Dietary Supplement
- 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:
- Recall initiation date
- Dec 31, 2014
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2015