Medical DeviceMar 27, 2019
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog recall — FDA Z-1026-2019
Updates to the Instructions for Use.
Class IIIFDA: TerminatedCook Medical Inc.
Latest records
Latest recalls — page 1269
The newest recall records with useful source details are listed here.
FoodMar 27, 2019
Gilster-Mary Lee Best Choice Pancake & Waffle Complete Mix Original 32oz recall — FDA F-1180-2019
Undeclared milk. Buttermilk pancake mix which contains milk was packed in Best Choice Pancake & Waffle Complete Mix Original retail cartons which do not declare milk as an ingredient.
Class IIFDA: TerminatedGilster-Mary Lee Corp.
FoodMar 27, 2019
Horizon Food Group Ne-Mo's Chocolate Cake Square with Cream Cheese Icing, item recall — FDA F-1177-2019
Firm received a complaint of a bird foot found in the baked product.
Class IIFDA: TerminatedHorizon Food Group
FoodMar 27, 2019
Lamb Weston item S0026, is formed star-shaped potato product that has been recall — FDA F-1181-2019
Lamb's Supreme Starz (Star-shaped Hash Brown Patties) are recalled due to contamination with foreign material.
Class IIFDA: TerminatedLamb Weston Inc.
FoodMar 27, 2019
Smoked Alaska Seafoods brand Smoked Alaska, packaged in 6.5 oz recall — FDA F-1174-2019
Smoked Silver Salmon product, 6.5 oz. jars and cans, brand Smoked Alaska, is recalled because it has the potential to be contaminated with Clostridium botulinum.
Class IIFDA: TerminatedSmoked Alaska Seafoods
FoodMar 27, 2019
Friendly Fruit Market dba Sid Wainer & Son JANSAL VALLEY Cocoa Dusted Chocolate Covered recall — FDA F-1175-2019
Product contains undeclared sesame seeds.
Class IIFDA: TerminatedFriendly Fruit Market dba Sid Wainer & Son
FoodMar 27, 2019
Horizon Food Group Ne-Mo's Red Velvet Cake Square with Cream Cheese Icing, item recall — FDA F-1178-2019
Firm received a complaint of a bird foot found in the baked product.
Class IIFDA: TerminatedHorizon Food Group
FoodMar 27, 2019
Horizon Food Group Ne-Mo's Birthday Cake Square with Buttercream Icing, item recall — FDA F-1179-2019
Firm received a complaint of a bird foot found in the baked product.
Class IIFDA: TerminatedHorizon Food Group
DrugMar 27, 2019
Rising Pharmaceuticals Valsartan Tablets 160 mg USP, 90 tablet bottles recall — FDA D-1054-2019
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class IIFDA: OngoingRising Pharmaceuticals, Inc.
DrugMar 27, 2019
Valsartan Tablets USP 80 mg, 90 count bottles recall — FDA D-1038-2019
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class IIFDA: OngoingAurobindo Pharma USA Inc.
DrugMar 27, 2019
Valsartan Tablets USP 320 mg, 90 count bottles recall — FDA D-1035-2019
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class IIFDA: OngoingAurobindo Pharma USA Inc.
DrugMar 27, 2019
Macleods Pharma Usa Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 recall — FDA D-1040-2019
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Class IIFDA: TerminatedMacleods Pharma Usa Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1034-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Rising Pharmaceuticals Valsartan Tablets 80 mg USP, 90 tablet bottles recall — FDA D-1053-2019
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class IIFDA: OngoingRising Pharmaceuticals, Inc.
DrugMar 27, 2019
Legacy Pharmaceutical Packaging Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles recall — FDA D-1049-2019
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected
Class IIFDA: OngoingLegacy Pharmaceutical Packaging LLC
DrugMar 27, 2019
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets recall — FDA D-1006-2019
Subpotent Drug.
Class IIIFDA: TerminatedTeva Pharmaceuticals USA
DrugMar 27, 2019
Advanced Pharma HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution recall — FDA D-1016-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Valsartan Tablets USP 160 mg, 90 count bottles recall — FDA D-1039-2019
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class IIFDA: OngoingAurobindo Pharma USA Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 500 mcg in 0.9% Sodium Chloride, QS 5 mL Injectable recall — FDA D-1020-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Advanced Pharma Phenylephrine HCl, 800 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable recall — FDA D-1028-2019
Lack of Assurance of Sterility
Class IIFDA: TerminatedAdvanced Pharma Inc.
DrugMar 27, 2019
Amlodipine and Valsartan Tablets USP 10mg/160mg, 30 count bottles recall — FDA D-1036-2019
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class IIFDA: OngoingAurobindo Pharma USA Inc.
DrugMar 27, 2019
Valsartan Tablets USP 40 mg, 30 count bottles recall — FDA D-1037-2019
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class IIFDA: OngoingAurobindo Pharma USA Inc.
DrugMar 27, 2019
Rising Pharmaceuticals Valsartan Tablets 320 mg USP, 90 tablet bottles recall — FDA D-1055-2019
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class IIFDA: OngoingRising Pharmaceuticals, Inc.
DrugMar 27, 2019
Preferred Pharmaceuticals Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle recall — FDA D-1051-2019
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Class IIFDA: TerminatedPreferred Pharmaceuticals, Inc.
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