🍎 Food Class I - Dangerous
Product label includes the ingredient CREAM but does not include Milk as the source.
All Recalls
95,075 total recalls in our database
Undeclared milk from Contains statement.
Lithium Orotate, 2.5MG, Distributed by Enjoy Nutrition, LLC. UPC#: 719318414002; 709750005289
Enjoy Nutrition, LLC;
🍎 Food Class I - Dangerous
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
READY MEALS TUNA SALAD OVER BED OF LETTUCE
Albertsons Companies
🍎 Food Class I - Dangerous
Potential contamination with Listeria monocytogenes.
Product is distributed in bulk brown paper bags.
PAX Spices & Labs
🍎 Food Class I - Dangerous
Foreign object (metal) in granulated onion ingredient.
Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
Tropicale Foods
🍎 Food Class I - Dangerous
Product label includes the ingredient CREAM but does not include Milk as the source.
🍎 Food Class I - Dangerous
Tuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled Japanese Style Breadcrumbs.
FG60007 Green Reviver Juice - point of service product
AND GO CONCEPTS
🍎 Food Class I - Dangerous
The firm manufactured and distributed to retailers unpasteurized juice products in violation of 21 CFR 120 Juice HACCP regulations
Lithium Orotate, 1MG, Distributed by Enjoy Nutrition, LLC. UPC#: 717340952714
Enjoy Nutrition, LLC;
🍎 Food Class I - Dangerous
Under potency / misbranding: product fails to meet labeled lithium orotate potency. (Downstream recall) from supplier of ingredient.
🍎 Food Class I - Dangerous
Product label includes the ingredient CREAM but does not include Milk as the source.
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., USA, Mahwah, NJ 07430. NDC 68462-164-05
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430 NDC: 68462-165-05
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites.
Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 47430, NDC 68462-164-05
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: low dissolution results
Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Goa- 403513 India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ, NDC 68462-380-01
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Failure results (above) were reported for the Dissolution (by UV) test for commercial annual stability at the long-term shelf life stability interval, wherein the dissolution results do not comply with L3 stage dissolution criteria.
Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162-01; Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-Bardez, Goa, 403513, India. Manufactured for Glenmark Pharmaceuticals, Inc., Mahwah, NJ, USA, NJ 07430.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carvedilol I Impurity above the current Acceptable Intake Level.
💊 Drugs Class I - Dangerous
Subpotent drug