FoodMay 23, 2018
HEALTHY FOOD INGREDIENTS Great Value Organic Ground Flax Seed, Net Wt recall — FDA F-1473-2018
Great Value Organic Ground Flax Seed has the potential to contain metal fragments.
Class IIFDA: TerminatedHEALTHY FOOD INGREDIENTS
Latest records
Latest recalls — page 1433
The newest recall records with useful source details are listed here.
FoodMay 23, 2018
eBars DIABEATIC Chocolate Berry Crunch bar NET WT 1.4 oz recall — FDA F-1443-2018
The firm was notified by the State of TN that the product contained undeclared peanuts.
Class IFDA: TerminatedeBars
DrugMay 23, 2018
Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg recall — FDA D-0802-2018
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as…
Class IIFDA: TerminatedSun Pharmaceutical Industries, Inc.
DrugMay 23, 2018
Boiron Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes recall — FDA D-0803-2018
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging…
Class IIIFDA: TerminatedBoiron Inc.
DrugMay 23, 2018
Prescript Pharmaceuticals Clindamycin 300 mg capsules, USP, 28-count M-Pak containers recall — FDA D-0808-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84) recall — FDA D-0816-2018
Defective delivery system
Class IIFDA: TerminatedL. Perrigo Company
DrugMay 23, 2018
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use recall — FDA D-0926-2018
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
Class IFDA: TerminatedAuroMedics Pharma LLC
DrugMay 23, 2018
Prescript Pharmaceuticals Clindamycin 150 mg capsules, USP, 30-count M-Pak container recall — FDA D-0805-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Riomet recall — FDA D-0818-2018
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
Class IIIFDA: TerminatedSun Pharmaceutical Industries, Inc.
DrugMay 23, 2018
Prescript Pharmaceuticals Chlorhexidine 0.12% liquid, 473 MILLITERS recall — FDA D-0807-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Mylan Pharmaceuticals Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count recall — FDA D-0819-2018
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 23, 2018
Mylan Pharmaceuticals Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count recall — FDA D-0820-2018
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class IIFDA: TerminatedMylan Pharmaceuticals Inc.
DrugMay 23, 2018
Apotex Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use recall — FDA D-0839-2018
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class IFDA: TerminatedApotex Inc.
DrugMay 23, 2018
Prescript Pharmaceuticals Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP recall — FDA D-0809-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers recall — FDA D-0806-2018
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C…
Class IIFDA: TerminatedPrescript Pharmaceuticals, Inc.
DrugMay 23, 2018
Apotex Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use recall — FDA D-0840-2018
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Class IFDA: TerminatedApotex Inc.
VehicleMay 17, 2018
Chrysler wiring recall — NHTSA campaign 18V332000
Chrysler (FCA US LLC) is recalling certain 2014-2018 Dodge Journey, Charger and Durango, RAM 2500, 3500, 3500 Cab Chassis (more than 10,000lb), 4500 Cab Chassis and 5500 Cab Chassis, Jeep…
wiringChrysler (FCA US LLC)
Medical DeviceMay 16, 2018
Ninepoint Medical NvisionVLE Low-Profile Optical Probe recall — FDA Z-1781-2018
Distal tips of the probes may detach from the probe shaft during use.
Class IIFDA: TerminatedNinepoint Medical Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Infant, with mask, 40inch oxygen reservoir tubing recall — FDA Z-1559-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Deerfield Imaging IMRIS IMRI 1.5T AND 3T S System Product Usage: The IMRIS intraoperative recall — FDA Z-1645-2018
The DC power to the IFOSS collision detector control panel at your facility is being adversely affected by the magnetic field. Our investigation shows the magnetic field is causing the…
Class IIFDA: TerminatedDeerfield Imaging, Inc.
Medical DeviceMay 16, 2018
Siemens Healthcare Diagnostics ADVIA Centaur Folate (FOL) recall — FDA Z-1689-2018
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus,…
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceMay 16, 2018
Zimmer Biomet Gentle Threads, Interference Screw recall — FDA Z-1739-2018
Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.
Class IIFDA: TerminatedZimmer Biomet, Inc.
Medical DeviceMay 16, 2018
Vyaire Medical AirLife Resuscitation, Adult, with mask, oxygen reservoir bag Product Usage recall — FDA Z-1547-2018
The mask component on various lots of the resuscitation devices have been identified as having the potential to exhibit a sticking condition which may result in a difficult to/unable to…
Class IFDA: TerminatedVyaire Medical
Medical DeviceMay 16, 2018
Datascope BEQ-T 25501 3/8" Better Bladder Pack, Custom Tubing Kit, Catalog No. 709000370 recall — FDA Z-1723-2018
The Better Bladder device provided as part of some custom tubing kits has been recalled by its manufacturer. Seal separation from the housing may allow air to enter the housing and collapse…
Class IIFDA: TerminatedDatascope Corporation
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