FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
by ACCORD HEALTHCARE, INC.
- Reason
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
by ACCORD HEALTHCARE, INC.
- Reason
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Published
- November 6, 2024
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404866, UPC 13454 38152, HMS Hatch Chicken Enchilada Ki…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 406873, UPC 40134 30852, Home Chef Asian Style Chicken…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 406581, UPC 40134 30435, Home Chef Kit Street Taco Chic…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 406897,UPC 13454 38407, Asian Style Stir Fry Single Ser…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 406740, UPC 13454 38316, Asian Style Chicken Stir Fry K…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404977, UPC 13454 38191, Green Chile Chicken Enchilada…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Item 404790, UPC 13454 38101, Ginger Chicken Broccoli Salad…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Reser's Fine Foods, Inc.
- Product
- Item 401311, UPC 13454 35855, Caesar Salad Kit 2/6 lbs. Dist…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404700, UPC 13454 38075, Premium Street Taco Kit With T…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404711, UPC 13454 38082, Don Pancho Kit OP Street Taco…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404710, UPC 13454 38080, Chicken Street Taco Kit with T…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404764, UPC 71117 12500, Don Pancho Chicken Street Taco…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404852, UPC 71117 12507, Don Pancho Chicken Quesadilla…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 404856, UPC 71117 12506, Don Pancho Creamy Green Chile…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Reser's Fine Foods, Inc.
- Product
- Item 407120, UPC 13454 38495, Bistro 28 Chicken Street Tacos…
- Reason
- Meal kits contain cooked chicken which was recalled due to contamination with Listeria monocytogenes
- Published
- November 6, 2024
- Distribution
- The firm distributed meal kits directly…
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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