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Drug recalls

Drug recalls from FDA, newest first.
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22 recalls

Sterling Pharmaceutical Services Lubricant Eye Drops and Ointments

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

ARUP Laboratories Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor taking an unlicensed, unapproved, or experimental medication.

Moderate risk, FDA, Blood donor screening

American Red Cross Apheresis Platelets

Apheresis Platelets were distributed without testing for pH or platelet yield.

Moderate risk, FDA, Quality testing problem

Vitalant Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed from a donor with travel history to a malaria endemic area but not assessed for residency.

Moderate risk, FDA, Blood donor screening

CorneaGen Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Iowa Lions Eye Bank Cornea

Corneas were processed using an expired viewing chamber.

Moderate risk, FDA

CorneaGen Cornea

Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.

Moderate risk, FDA, Blood donor screening

OneLegacy Cornea

Corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed.

Moderate risk, FDA, Blood donor screening

Rocky Mountain Lions Eye Bank Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Eversight Cornea

Cornea, recovered from a donor in which donor eligibility was not adequately determined, was distributed.

Moderate risk, FDA, Blood donor screening

Precision Ocular Network - Bartlett Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Precision Ocular Network Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.

Low risk, FDA, Quality testing problem

Department of Defense Navy Whole Blood

Whole Blood tested negative for anti-HTLV but was collected from a donor who previously tested reactive.

Moderate risk, FDA, Blood donor screening

HCSC-Blood Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were exposed to unacceptable storage temperatures.

Low risk, FDA, Processing problem

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were incorrectly labeled as irradiated and distributed.

Moderate risk, FDA, Labeling error

Department of Defense Air Force Red Blood Cells

Red Blood Cells were collected from a donor who previously tested repeatedly reactive for HTLV-I antibody.

Moderate risk, FDA, Blood donor screening

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red blood cells were collected from a donor with low hemoglobin or without a hemoglobin check.

Moderate risk, FDA, Blood donor screening

Mississippi Blood Services Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

Moderate risk, FDA, Blood donor screening

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced product had platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

Eversight Illinois Cornea

Cornea was processed without the proper antibiotic soak.

Moderate risk, FDA, Processing problem

2 recalls

Endo Dexmedetomidine HCl in 0.9% Sodium Chloride Injection

Dexmedetomidine HCL in 0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object

Menow Sunscreen Pressed Powder SPF35 PA+++

MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

3 recalls

ICU Medical 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection may be mixed up with Potassium Chloride Injection, which can cause adverse events and potentially fatal outcomes.

High risk, FDA, Labeling error

Hospira Dopamine HCl Injection

Dopamine HCl injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Dechra Veterinary Products Puralube Vet Ointment

Puralube Vet Ointment has cGMP deviations.

Moderate risk, FDA, Manufacturing problem

2 recalls

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

American National Red Cross Red Blood Cells and PF24 Plasma

American National Red Cross Red Blood Cells and PF24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

Moderate risk, FDA, Sterility problem

6 recalls

Taro Nystatin Cream

Nystatin Cream, USP, failed stability specifications.

Moderate risk, FDA, Quality testing problem

Amneal Phytonadione Injectable Emulsion

Phytonadione Injectable Emulsion failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

American National Red Cross Apheresis Plasma

Apheresis PF24RT24 Plasma was collected in a manner that compromises the sterility of the collection system.

Moderate risk, FDA, Sterility problem

American Red Cross Leukocytes Reduced Red Blood Cells

Red Blood Cells, Leukocytes Reduced were distributed from a donor with travel history to a malaria endemic area but not assessed for residency.

Moderate risk, FDA, Blood donor screening

Innovative Blood Resources Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who previously tested reactive for Hepatitis B core antigen antibody.

Moderate risk, FDA, Blood donor screening

American National Red Cross Red Blood Cells and Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF and Red Blood Cells were collected from a donor who previously tested reactive for Hepatitis B core antigen.

Moderate risk, FDA, Blood donor screening

4 recalls

A&P Creations biQ-FEL and X10 Natural Enhancement Supplements

BiQ-FEL contains undeclared Sildenafil and Tadalafil, which may lower blood pressure to dangerous levels.

High risk, FDA, Hidden drug ingredient

Safecor Health Fluphenazine HCl Oral Elixir

Fluphenazine HCl Elixir failed stability specifications.

Moderate risk, FDA, Quality testing problem

New York Blood Center Enterprises Plasma and Red Blood Cells

Liquid Plasma, collected in an expired collection kit, was distributed.

Low risk, FDA

LifeShare Blood Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had a platelet count higher than acceptable.

Moderate risk, FDA, Quality testing problem

2 recalls

Centric Compounding Glutathione, Myers Cocktail and Tri-Immune Boost Injections

Centric Compounding injections have been found to be compounded with a Glutathione API containing elevated endotoxin levels.

High risk, FDA, Sterility problem

Taro Lidocaine Ointment

Lidocaine Ointment USP, 5%, Speermint Flavor failed content uniformity specifications and assay specifications.

Moderate risk, FDA, Quality testing problem

1 recall

OurPharma FentaNYL Citrate Injection Solution

FentaNYL Citrate Injection solution has a labeling discrepancy between the IV bag expiry and the product expiry.

Moderate risk, FDA, Labeling error

5 recalls

ImprimisRx NJ Povidone Iodine and Proparacaine Ophthalmic Solution

The ophthalmic solution is subpotent.

Low risk, FDA, Wrong drug strength

Ajanta Pharma Fluphenazine Hydrochloride Tablets

Fluphenazine Hydrochloride Tablets failed impurity specifications during stability testing.

Low risk, FDA, Drug impurity

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were possibly exposed to unacceptable temperatures due to extended transit time.

Moderate risk, FDA, Processing problem

American National Red Cross PF24 Plasma and Red Blood Cells

PF24 Plasma and Red Blood Cells, Leukocytes Reduced, with or without irradiation, were collected from donors whose arm inspections were not properly performed.

Low risk, FDA, Blood donor screening

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced did not meet platelet yield specifications.

Moderate risk, FDA, Quality testing problem

4 recalls

SUPPLX.Com Dietary Supplements

Business Pill and Branch Manager for Men contain undeclared yohimbine, which can cause severe hypertension and heart problems.

FDA

Stanford Blood Center Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Red blood cells and a fibrinogen complex were collected with potential air contamination.

Moderate risk, FDA, Contamination

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced were distributed with platelet yield that did not meet specifications.

Moderate risk, FDA, Quality testing problem

Medic Apheresis Platelets and Platelets Extended Dating

Apheresis Platelets, Leukocytes Reduced, Irradiated, with a platelet count higher than was acceptable, were distributed.

Moderate risk, FDA, Quality testing problem