Glenmark Carvedilol 12.5 mg Tablets Recalled for NNCI Impurity Exceeding FDA Limit (2025)
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Recall database
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Unapproved Drug Claims and Misbranded.
Maquet Cardiovascular recalled 98 Vasoview Hemopro 3 EVH systems nationwide across FL, IL, MD and TX after 16 out-of-box failure complaints. No serious injuries were reported. The failures occurred during limited launch before clinical use.
Unapproved Drug Claims and Misbranded.
The Candy Barn recalled 665 packages of Chocolate Pecan Fudge on August 6, 2025. The product lacks proper allergen labeling for pecans and eggs, posing a high risk to consumers. The recall affects products distributed in Kalona, Iowa.
The Candy Barn recalled 665 packages of English Toffee on August 6, 2025. The product contains undeclared pecans, posing a risk to those with tree nut allergies. Consumers should not eat the candy and should seek a refund or replacement.
The Candy Barn recalled 665 packages of Maple Nut Fudge on August 6, 2025. The product contains undeclared allergens: pecans and eggs. Consumers should not consume the fudge and seek refunds.
The Candy Barn recalled 665 packages of its Chocolate Fudge on August 6, 2025. The product does not list egg in the allergen statement, posing a risk to those with egg allergies. Consumers should not consume the product and seek a refund.
The Candy Barn recalled 665 packages of Chocolate Mint Fudge on August 6, 2025. The product lacks proper allergen labeling for egg, posing a risk to consumers. The fudge was distributed in Kalona, Iowa at two grocery locations.
The Candy Barn recalled 665 packages of Pecan Toffee Clusters on August 6, 2025. The recall stems from a labeling issue where pecans were not listed in the allergen statement. Consumers should not consume these products and seek refunds.
Unapproved Drug Claims and Misbranded.
Unapproved Drug Claims and Misbranded.