BTREX PLUS Dietary Supplement 100 Caplets
Reason CGMP Deviations: Presence of damaged tablets
Class III means the product is unlikely to cause harm but breaks an FDA rule - most often a labeling or registration problem.
1,762 recalls, newest first.
Reason CGMP Deviations: Presence of damaged tablets
Reason Cup label identifies product as Peaches, product inside cup, and label on lid is Mixed Fruit
Reason Foreign capsules included in bottle. Undeclared ingredients.
Reason Failure to manufacture product in accordance with 21CFR part 114: Acidified Foods
Reason cGMP Deviation: Presence of damaged tablets
Reason Firm determined that pesticide Bifenazate MRL is out of compliance for the US market. US MRL = 5ppm. Product tested = 5.8ppm.
Reason Incorrect active ingredient is listed on product label
Reason Elevated water activity level in shelf-stable products.
Reason Elevated water activity level in shelf-stable products.
Reason Elevated water activity level in shelf-stable products.
Reason Elevated water activity level in shelf-stable products.
Reason Elevated water activity level in shelf-stable products.
Reason Elevated water activity level in shelf-stable products.
Reason Jelly contains undeclared FD&C Red #40
Reason Fish decomposition.
Reason One lot of uncooked shrimp was inadvertently packaged as cooked shrimp.
Reason Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
Reason Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
Reason Product contains undeclared FD&C Red No. 40.
Reason Product contains undeclared FD&C Red No. 40.
Reason Undeclared Red #40
Reason Undeclared ingredients on retail packaging, including but not limited to certified colors Red #40 and Blue #1
Reason Pasteurized donor human milk may contain trace amounts of dextromethorphan.
Reason Incorrect labeling on bottom of packaging (undeclared peanuts).
Reason The firm received a consumer complaints that the product was spoiled.