Medical DeviceSep 26, 2018
Exactech Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee recall — FDA Z-3209-2018
Potentially have non-conforming internal threads.
Class IIFDA: OngoingExactech, Inc.
September 2018 recalls — page 4
These records include useful source details for the selected month.
Medical DeviceSep 26, 2018
Degania Silicone Foley Catheter with temperature sensor 400TM 16FR, Catalogue Number recall — FDA Z-2766-2018
The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.
Class IIFDA: TerminatedDegania Silicone, Ltd.
FoodSep 26, 2018
Shearers Foods Yellow Corn Tortilla Chips packaged under the following brand recall — FDA F-1967-2018
Corn Chip products are being recalled due to possible metal contamination.
Class IIFDA: TerminatedShearers Foods, LLC
FoodSep 26, 2018
Shearers Foods White Corn Tortilla Chips packaged under the following brand recall — FDA F-1966-2018
Corn Chip products are being recalled due to possible metal contamination.
Class IIFDA: TerminatedShearers Foods, LLC
FoodSep 26, 2018
Stewart's Shops 1 pint, keep frozen, UPC: 082086444718 recall — FDA F-1970-2018
Product is mislabeled. Some pint containers of Caramel Cone Crunch ice cream may have been packaged incorrectly with a "Crumbs Along the Mohawk" lid.
Class IIIFDA: TerminatedStewart's Shops Corp.
FoodSep 26, 2018
CedarLane Organic Salads recall — FDA F-1969-2018
Discovery that the product is labeled as gluten free but contains wheat (couscous). Wheat is not declared as an allergen
Class IIFDA: TerminatedCedarlane Natural Foods Inc/Frankly Fresh Foods Inc.
FoodSep 26, 2018
Market of Choice Sesame Noodle Salad Vegan, packaged in 8 oz recall — FDA F-1973-2018
Sesame Noodle Salad Vegan is recalled due to undeclared egg.
Class IFDA: TerminatedMarket of Choice Inc.
DrugSep 26, 2018
Beaumont Bio-med Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL recall — FDA D-1194-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
Beaumont Bio-med Muscle & Joint Pain Relief Homeopathic Formula, 2 FL recall — FDA D-1196-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
Bupropion Hydrochloride ER Tablets, USP 150 mg recall — FDA D-1212-2018
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in…
Class IIIFDA: TerminatedInvaGen Pharmaceuticals, Inc.
DrugSep 26, 2018
Beaumont Bio-med Arthritis Pain Relief Homeopathic Formula, 2 FL recall — FDA D-1199-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
QuVa Pharma Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative recall — FDA D-0003-2019
Subpotent Drug: Product may not have the active ingredient present in the bag.
Class IFDA: TerminatedQuVa Pharma, Inc.
DrugSep 26, 2018
Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle recall — FDA D-1204-2018
Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
Class IIFDA: TerminatedTorrent Pharma Inc.
DrugSep 26, 2018
Beaumont Bio-med Colds & Flu Response Homeopathic Formula, 2 FL recall — FDA D-1198-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle recall — FDA D-1214-2018
Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during…
Class IIIFDA: TerminatedLUPIN SOMERSET
DrugSep 26, 2018
Beaumont Bio-med Sinus Response Homeopathic Formula, 2 FL recall — FDA D-1193-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
Beaumont Bio-med Allergy & Hay Fever Relief Homeopathic Formula, 2 FL recall — FDA D-1197-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
Beaumont Bio-med Diarrhea Response Homeopathic Formula, 2 FL recall — FDA D-1195-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
DrugSep 26, 2018
Tizanidine HCl Tablets, USP 2mg, 150-count bottles recall — FDA D-1191-2018
Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
Class IIFDA: TerminatedDr. Reddy's Laboratories, Inc.
DrugSep 26, 2018
Beaumont Bio-med Skin Irritation & Itch Response Homeopathic Formula, 2 FL recall — FDA D-1192-2018
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class IIFDA: TerminatedBeaumont Bio-med, Inc.
VehicleSep 26, 2018
Volkswagen Jetta headlights recall — NHTSA campaign 18V671000
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2019 Volkswagen Jetta vehicles equipped with LED headlights. The passenger side headlight may be incorrectly positioned,…
headlightsVolkswagen Group of America, Inc.
Medical DeviceSep 19, 2018
Intuitive Surgical da Vinci X/Xi EndoWrist 8mm Monopolar Curved Scissors Model No. 470179-14 recall — FDA Z-3025-2018
Monopolar Curved Scissor (MCS) instruments may be susceptible to developing cracks near the proximal edge of the extension tube. These cracks may fracture the plastic surrounding the…
Class IIFDA: OngoingIntuitive Surgical, Inc.
Medical DeviceSep 19, 2018
Zimmer Biomet Affixus Hip Fracture Nail Left 125 11 mm x 400 mm, Item Number: 814411400 recall — FDA Z-3094-2018
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceSep 19, 2018
Zimmer Biomet Affixus Hip Fracture Nail Left 125 9 mm x 320 mm, Item Number: 814409320 recall — FDA Z-3081-2018
The set screw is not able to advance or reverse from the original position in the nail.
Class IIFDA: TerminatedZimmer Biomet, 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.