Why it was recalled
CGMP Deviations: Presence of damaged tablets
Product description
BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
Lot numbers, UPCs & expiration codes
Lot# 32179, Exp. 9/2022 Lot# 33278, Exp. 12/2022
Where it was sold
Domestic distribution only-PR
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-0540-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 13, 2020
- FDA report date
- May 26, 2021
- Quantity
- lots #32179 1405 and Lot #33278 - 0.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lopez Gonzalez Santana Corporation
Original FDA data
Every field from FDA enforcement report F-0540-2021, exactly as published.
Show all FDA fields
- City
- Rio Piedras
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 87759
- Address
- Calle De Diego # 488 Altos
- Code information
- Lot# 32179, Exp. 9/2022 Lot# 33278, Exp. 12/2022
- Postal code
- 00924
- Report date
- May 26, 2021
- Product type
- Food
- Recall number
- F-0540-2021
- Classification
- Class III
- Recalling firm
- Lopez Gonzalez Santana Corporation
- Product quantity
- lots #32179 1405 and Lot #33278 - 0.
- Termination date
- Oct 8, 2021
- Reason for recall
- CGMP Deviations: Presence of damaged tablets
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples)
- Distribution pattern
- Domestic distribution only-PR
- Recall initiation date
- Jul 13, 2020
- Initial firm notification
- Center classification date
- May 19, 2021