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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,957 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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9 recalls that day

La Colonia Foods Requeson Cheeses

La Colonia Foods Requeson Cheeses may be contaminated with Listeria.

High risk, FDA, Listeria

TNVitamins Organic Moringa Capsules and Powder

TNVitamins 100% Organic Moringa Capsules and Powder are contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

MFV Compounding Pharmacy Diclofenac Sodium Eye Ointment

Diclofenac Sodium 0.1% Eye Ointment contains Bacillus cereus.

High risk, FDA, Contamination

Blue Ribbon Classics French Vanilla

The product has elevated coliforms.

Moderate risk, FDA, Ended, Contamination

Medline Convenience Kits Containing Recalled Swan-Ganz Catheters

Medline Convenience kits contain Swan-Ganz catheters with a hub that may leak, causing infection, medication loss, or blood loss.

Moderate risk, FDA, Device defect

Mentor Texas Syringes

Expired syringes were distributed due to a distribution system control failure.

Moderate risk, FDA, Device defect

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99092

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Labeling error, FDA event number 99091

Mississippi Blood Services Apheresis and Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

9 recalls that day

High Valley Orchard Chocolate Covered Raisins

Chocolate covered raisins contain undeclared peanut, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared peanut

Bakr Brown Butter Chocolate Chunk Ready to Bake Cookie Dough

Bakr Brown Butter Chocolate Chunk Cookie Dough may contain undeclared soy, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared soy

Povi-One, 10% Povidone-Iodine Oral Antiseptic

Povi-One, 10% Povidone-Iodine Oral Antiseptic has sub potency.

Moderate risk, FDA, Wrong drug strength

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump

The Intera Oncology Intera 3000 Hepatic Artery Infusion Pump has potential for leakage along the drug pathway.

Moderate risk, FDA, Device defect

Medline Convenience Kits with 10mL Polycarbonate Colored Syringes

Convenience kits with polycarbonate syringes have unapproved design changes.

Moderate risk, FDA, Unapproved product

Abiomed Impella CP Sets and Low Profile Introducer Kits

Abiomed Impella CP Sets and Low Profile Introducer Kits have potential for thrombus formation during prolonged use of the introducer.

High risk, FDA, Device defect

Mississippi Blood Services Apheresis Platelets and Red Blood Cells

Apheresis red blood cells and platelets labeled as leukocytes reduced were not tested to verify the residual white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Medic Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

ARUP Laboratories Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed without pH testing.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

19 recalls that day

Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags

Incorrect product formulation: bag did not contain copper and famotidine per label.

Moderate risk, FDA, Labeling error

Sun Pharmaceutical Perampanel CIII Tablets

Perampanel CIII Tablets labeled 6mg may contain a 10mg tablet.

Moderate risk, FDA, Labeling error

Camber Lacosamide Tablets

Lacosamide Tablets may contain a foreign tablet, Selexipag.

Moderate risk, FDA, Foreign object

El David Gelee, Bonbons with Fruits Soft & Juicy

El David Gelee bonbons contain undeclared colors.

Moderate risk, FDA, Undeclared color or additive

ANI Pharmaceuticals Hydroxyzine Hydrochloride Oral Solution

HydrOXYzine Hydrochloride Oral Solution contains a foreign substance.

Low risk, FDA, Foreign object

Philips Telemetry Monitor 5500 1.4 GHz

The telemetry monitor may reset to a default state, causing loss of configuration and failure to reconnect.

Moderate risk, FDA, Labeling error

Lunch Box Kitchen Roast Beef and Cheddar Closed Face Sandwich

Roast beef and cheddar closed face sandwich is mislabeled as turkey and cheddar.

Low risk, FDA, Ended, Labeling error

Persona Revision Trabecular Metal Femoral Distal Augment

The Persona Revision Trabecular Metal Femoral Distal Augment may contain a posterior augment inside its package.

Moderate risk, FDA, Device defect

Thuvera Laser Console

The Thuvera Laser Console has a software anomaly that causes a false display of error code 5018.

Moderate risk, FDA, Software defect

Medline Convenience Kits

Medline Convenience Kits contain Lidocaine and Bupivacaine injections with quality issues identified during an FDA inspection of the supplier.

High risk, FDA, Device defect

GE Healthcare AW Server 3.2 ext.6.5

GE Healthcare AW Server 3.2 ext.6.5 may open the previous patient's exam instead of the intended one, leading to misdiagnosis.

Moderate risk, FDA, Device defect

PReye Vitamin See Antioxidant Preservative Free Eye Drops

PReye Vitamin See Antioxidant Preservative Free Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Octopus 4, Evolution, and Evolution AS Tissue Stabilizer

During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned.

Moderate risk, FDA, Manufacturing problem

Surgify Halo Surgical Drills and Burrs

Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).

Moderate risk, FDA, Device defect

Stryker Neurovascular Inzone Detachment System

The Inzone Detachment System may experience premature battery drain, causing it to not power on or detach a coil as intended.

Moderate risk, FDA, Device defect

New York Blood Center Fresh Frozen Plasma and Red Blood Cells

The products were collected from donors who previously tested reactive for the antibody to Hepatitis B core antigen on more than one occasion.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Kentucky Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were exposed to unacceptable shipping temperatures.

Low risk, FDA, Ended, Hospital use, Processing problem

Vitalant Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

Abbott Determine HIV 1/2 Ag/Ab Combo

Determine HIV 1/2 Ag/Ab Combo 25T kits may give false positive results due to a subcomponent.

Moderate risk, FDA, Device defect

10 recalls that day

Direct Rx Duloxetine and Cymbalta Capsules

Duloxetine D/R contains an impurity above the FDA recommended interim limit.

Moderate risk, FDA, Drug impurity

Acumed Hexalobe Screws

Hexalobe screws used with wrist fixation system may break during use.

Moderate risk, FDA, Manufacturing problem

Amgen Corlanor and Sensipar Tablets

Amgen is recalling its Corlanor (ivabradine) tablets because of the presence of foreign substance.

Moderate risk, FDA, Foreign object

Zimmer Off-Axis Comprehensive Shoulder System Reamer Guides

The plastic guides were catching during reaming, leading to breakage.

Moderate risk, FDA, Device defect

Joy Gourmet Foods Lassi

Joy Gourmet Foods Lassi is not adequately pasteurized.

Moderate risk, FDA, Processing problem

PFM Medical Multi-Snare Sets

The Multi-Snare Set failed to meet biocompatibility requirements, which could cause localized inflammation and tissue irritation.

Moderate risk, FDA, Device defect

Ventec Life Systems VOCSN+Pro Package

The VOCSN+Pro respiratory system may have a damaged back-up battery, causing the backup alarm not to activate during power loss.

Moderate risk, FDA, Device defect

Medic Apheresis Platelets, Leukocytes Reduced, Irradiated

The platelets did not meet specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor not tested for Chagas.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem

10 recalls that day

Major Methylergonovine Maleate Tablets

Major Methylergonovine Maleate Tablets, USP, 0.2 mg may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Midwest Legacy Raw Beef Dog Food BLT & Bones

Midwest Legacy Raw Beef Dog Food BLT & Bones may be contaminated with Salmonella, Listeria, and E. coli.

High risk, FDA, Ended, Salmonella

Ajanta Pharma Fenofibrate Capsules

The product has CGMP deviations.

Moderate risk, FDA, Manufacturing problem