DrugOct 21, 2015
Ohm Laboratories Good Neighbor Pharmacy Loratadine Orally Disintegrating Tablets, USP, 10 mg recall — FDA D-0027-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
October 2015 recalls — page 5
These records include useful source details for the selected month.
DrugOct 21, 2015
FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle recall — FDA D-0011-2016
CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
Class IIIFDA: TerminatedBoehringer Ingelheim Roxane Inc.
DrugOct 21, 2015
Tribute Pharmaceuticals US Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) recall — FDA D-0016-2016
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class IIIFDA: TerminatedTribute Pharmaceuticals US Inc.
DrugOct 21, 2015
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution recall — FDA D-0010-2016
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class IIFDA: TerminatedNephron Pharmaceuticals Corp.
DrugOct 21, 2015
Ohm Laboratories QC Quality Choice Loratadine Orally Disintegrating Tablets, USP 10 mg recall — FDA D-0019-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugOct 21, 2015
Ohm Laboratories CareOne Original Prescription Strength, Allergy Relief, Loratadine Orally recall — FDA D-0022-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugOct 21, 2015
Ferring Pharmaceuticals Bravelle 75 IU recall — FDA D-0015-2016
Subpotent Drug
Class IIIFDA: TerminatedFerring Pharmaceuticals Inc.
DrugOct 21, 2015
Ohm Laboratories Wal-itin Loratadine Orally Disintegrating Tablets, USP, 10 mg recall — FDA D-0038-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugOct 21, 2015
Ohm Laboratories Discount Drug Mart Food Fair, Original Prescription Strength, Loratadine recall — FDA D-0024-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugOct 21, 2015
The Mentholatum Co WellPatch Capsaicin Pain Relief Patch, 0.025% Natural Capsaicin, External recall — FDA D-0018-2016
Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or…
Class IIFDA: TerminatedThe Mentholatum Co.
DrugOct 21, 2015
Tribute Pharmaceuticals US Fenofibric Acid Tablets 105 mg recall — FDA D-0017-2016
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Class IIIFDA: TerminatedTribute Pharmaceuticals US Inc.
DrugOct 21, 2015
Ohm Laboratories TopCare LORATIDINE ORALLY DISINTEGRATING TABLETS, , USP, 10 mg recall — FDA D-0035-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugOct 21, 2015
Ohm Laboratories Safeway Care Loratadine Orally Disintegrating Tablets, USP, 10 mg recall — FDA D-0034-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
DrugOct 21, 2015
Ohm Laboratories Sunmark loratadine Orally Disintegrating Tablets, USP, 10 mg recall — FDA D-0037-2016
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class IIIFDA: TerminatedOhm Laboratories, Inc.
FoodOct 14, 2015
NewStar Fresh Foods organic girl - good clean greens baby spinach - tender recall — FDA F-0003-2016
Detection of elevated level of Cadmium in the product.
Class IIFDA: TerminatedNewStar Fresh Foods, LLC
FoodOct 14, 2015
Caribou Coffee Company Net Wt recall — FDA F-0006-2016
Biscotti Almond and Biscotti Chocolate Chip Toffee Pecan are being recalled because they are labeled inadequately. Soy lecithin, a sub-ingredient, was missing from the ingredient list.
Class IIFDA: TerminatedCaribou Coffee Company Inc.
FoodOct 14, 2015
Caribou Coffee Company Net Wt recall — FDA F-0005-2016
Biscotti Almond and Biscotti Chocolate Chip Toffee Pecan are being recalled because they are labeled inadequately. Soy lecithin, a sub-ingredient, was missing from the ingredient list.
Class IIFDA: TerminatedCaribou Coffee Company Inc.
FoodOct 14, 2015
Reily Foods Co Blue Plate recall — FDA F-0004-2016
One lot of Blue Plate Light Mayonnaise has the Blue Plate Mayonnaise ingredient statement and nutrition facts on the rear panel.
Class IIIFDA: TerminatedReily Foods Co.
DrugOct 14, 2015
Merck Sharp & Dohme, Wilson Facility Vytorin recall — FDA D-0007-2016
Presence of Foreign Tablet/Capsule: Vytorin 10 mg/40 mg tablets were found in bottles of Vytorin 10 mg/20 mg tablets.
Class IIFDA: TerminatedMerck Sharp & Dohme, Wilson Facility
DrugOct 14, 2015
Diabetes Corporation of America dba DCA Pharmacy Sermorelin 6mg/6mL Lyophilized Powder recall — FDA D-0006-2016
Lack of Assurance of Sterility: A recent FDA inspection found that this product was not being compounded in an area appropriate for lyophilization which may lead to a lack of sterility…
Class IIFDA: TerminatedDiabetes Corporation of America dba DCA Pharmacy
DrugOct 14, 2015
Daytrana recall — FDA D-0008-2016
Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Class IIFDA: TerminatedNoven Pharmaceuticals, Inc.
FoodOct 7, 2015
General Mills Cascadian Farm Organic Cut Green Beans, Net Wt recall — FDA F-3248-2015
General Mills is recall one lot of 10 ounce bags of frozen Cascadian Farm Cut Green Beans because one package tested positive for the presence of Listeria monocytogenes.
Class IIFDA: TerminatedGeneral Mills, Inc.
FoodOct 7, 2015
Real Foods Harvest Slaw Kit, product ID 028-07114, package in bulk case recall — FDA F-3254-2015
Undeclared peanuts. Peanuts were inadvertently added to salad kits instead of sunflower seeds and labels do not declare peanuts.
Class IFDA: TerminatedReal Foods, LLC
FoodOct 7, 2015
Savannah-Imperial LP- Savannah Sugar Refinery Imperial Sugar, Pure Granulated Sugar, Net wt recall — FDA F-3259-2015
Foreign matter (blue fiber) detected in product.
Class IIIFDA: TerminatedSavannah-Imperial LP- Savannah Sugar Refinery
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.