FoodNov 20, 2019
California New foods Country Baking Company recall — FDA F-0146-2020
Firm received consumer complaint of an allergic reaction after consumption.
Class IFDA: TerminatedCalifornia New foods
November 2019 recalls — page 16
These records include useful source details for the selected month.
FoodNov 20, 2019
California New foods Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at recall — FDA F-0141-2020
Firm received consumer complaint of an allergic reaction after consumption.
Class IFDA: TerminatedCalifornia New foods
FoodNov 20, 2019
Harris Teeter Supermarkets, LLC dba Hunter Farms Mint Chocolate Chip Ice Cream 1.5 QT recall — FDA F-0152-2020
The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.
Class IIFDA: OngoingHarris Teeter Supermarkets, LLC dba Hunter Farms
FoodNov 20, 2019
Pacific Coast Fruit Company Winter Citrus Slaw Kit, item #71909, UPC 20728 71909 recall — FDA F-0228-2020
The Winter Citrus Slaw Kit, item #71909, is recalled due to a potential contamination of Listeria monocytogenes.
Class IFDA: TerminatedPacific Coast Fruit Company
FoodNov 20, 2019
Harris Teeter PREMIUM SELECTIONS CHOCOLATE SATISFACTION ICE recall — FDA F-0150-2020
The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.
Class IIFDA: OngoingHarris Teeter Supermarkets, LLC dba Hunter Farms
FoodNov 20, 2019
California New foods Country Baking Company recall — FDA F-0147-2020
Firm received consumer complaint of an allergic reaction after consumption.
Class IFDA: TerminatedCalifornia New foods
FoodNov 20, 2019
Harris Teeter Supermarkets, LLC dba Hunter Farms THE FRESH MARKET Mint Chip OLD FASHIONED recall — FDA F-0153-2020
The firm discovered that the allergen soy was not declared in the ingredient statement or allergen declaration.
Class IIFDA: OngoingHarris Teeter Supermarkets, LLC dba Hunter Farms
FoodNov 20, 2019
Tonys Smoke House and Cannery Tony's Columbia Gorge Salmon, Skinless and boneless salmon recall — FDA F-0154-2020
Canned salmon product was recalled because it may have been under-processed and firm can't find the lot code in their canning records.
Class IIFDA: TerminatedTonys Smoke House and Cannery Inc.
FoodNov 20, 2019
California New foods Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at recall — FDA F-0144-2020
Firm received consumer complaint of an allergic reaction after consumption.
Class IFDA: TerminatedCalifornia New foods
FoodNov 20, 2019
Gilster-Mary Lee Food Lion Creamy Chocolate Frosting, Net Wt 16 OZ, Distributed recall — FDA F-0149-2020
Cream cheese frosting was put in a container labeled as Creamy Chocolate Frosting. The chocolate frosting label fails to declare the presence of the major food allergen Milk.
Class IIFDA: TerminatedGilster-Mary Lee Corp.
FoodNov 20, 2019
California New foods Carolyn's Cookie Company - Frozen Cookie Doughballs - Bake at recall — FDA F-0142-2020
Firm received consumer complaint of an allergic reaction after consumption.
Class IFDA: TerminatedCalifornia New foods
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Adipose, 10 mL Sterile multi-dose vial recall — FDA D-0330-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Male+, 10 mL Sterile multi-dose vial recall — FDA D-0347-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
Apotex Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer recall — FDA D-0314-2020
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class IIFDA: CompletedApotex Inc.
DrugNov 20, 2019
Golden State Medical Supply GSMS: Ranitidine Capsules 300 mg recall — FDA D-0308-2020
CGMP Deviations: Presence of NDMA impurity detected in product.
Class IIFDA: TerminatedGolden State Medical Supply Inc.
DrugNov 20, 2019
Isotretinoin Capsules, USP 10 mg recall — FDA D-0321-2020
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class IIIFDA: TerminatedAmneal Pharmaceuticals, Inc.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Neuro, 10 mL Sterile multi-dose vial recall — FDA D-0346-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Systemic Detox, 10 mL Sterile multi-dose vial recall — FDA D-0331-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 recall — FDA D-0532-2020
Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection
Class IIFDA: TerminatedKVK-Tech, Inc.
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Relief +, 10 mL Sterile multi-dose vial recall — FDA D-0342-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-MuSkel-Neural, 10 mL Sterile multi-dose vial recall — FDA D-0327-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Facial, 10 mL Sterile multi-dose vial recall — FDA D-0344-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
8046255 Canada Inc. DBA Viatrexx Viatrexx-Ithurts, 10 mL Sterile multi-dose vial recall — FDA D-0329-2020
Lack of Assurance of Sterility: products manufactured in a manner than cannot guarantee its sterility.
Class IIFDA: Terminated8046255 Canada Inc. DBA Viatrexx
DrugNov 20, 2019
Apotex Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer recall — FDA D-0319-2020
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Class IIFDA: CompletedApotex Inc.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.