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Drug recalls

Drug recalls from FDA, newest first.
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13 recalls

FOCUS PI Hypromellose 0.7% Formula

FOCUS PI Hypromellose 0.7% Formula lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Zoladex (Goserelin) Implant

Zoladex (goserelin) implant was exposed to non-temperature-controlled conditions for 25.5 hours.

Moderate risk, FDA, Processing problem

American Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested antigen positive.

Moderate risk, FDA, Labeling error

American National Red Cross Red Blood Cells Leukocytes Reduced Irradiated

Red Blood Cells, Leukocytes Reduced, Irradiated are misbranded and were distributed.

Moderate risk, FDA, Mislabeled product

American Red Cross Leukocytes Reduced Red Blood Cells

Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested positive.

Moderate risk, FDA, Labeling error

Amneal Pharmaceuticals Estradiol Gel

Estradiol Gel packets may be empty or partially full.

Moderate risk, FDA, Packaging defect

Central California Blood Center Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Pathogen Reduced Cryoprecipitated Fibrinogen Complex and Red Blood Cells were collected from a donor not re-entered after positive Chagas testing.

Moderate risk, FDA, Blood donor screening

American National Red Cross Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced were misbranded and distributed.

Moderate risk, FDA, Mislabeled product

Department of Defense - Army Blood Components

Department of Defense - Army Blood Components, for which arm preparation may have been performed incorrectly, were distributed.

Moderate risk, FDA

Oklahoma Lions Eye Bank Cornea

Corneas were distributed from a donor who was not free from risk factors for infection.

Moderate risk, FDA, Blood donor screening

Eversight 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

American National Red Cross Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced were misbranded when distributed.

Moderate risk, FDA, Mislabeled product

Versiti Illinois Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

11 recalls

Ajanta Pharma Ranolazine Extended-Release Tablets

Ranolazine Extended-Release Tablets fail dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Saving Sight Cornea

Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.

Low risk, FDA, Blood donor screening

VisionGift Cornea

The cornea was distributed without ensuring the donor was free from risk factors for and clinical evidence of relevant communicable disease agents and diseases.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications and was distributed.

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced did not meet platelet yield specifications and was distributed.

Moderate risk, FDA, Quality testing problem

6 recalls

New York Blood Center Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

Blood Assurance Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed without a label indicating they contained antibodies.

Low risk, FDA, Labeling error

West TN Regional Blood Center Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for pH and were distributed.

Moderate risk, FDA, Quality testing problem

LifeStream Blood Bank Red Blood Cells, Leukocytes Reduced

Red blood cells labeled as leukocytes reduced were not tested to verify white blood cell count.

Moderate risk, FDA, Quality testing problem

OneBlood Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, Quality testing problem

HCSC-Blood Center Plasma and Red Blood Cells

HCSC-Blood Center Plasma and Red Blood Cells, collected from a donor for whom donor eligibility screening was incomplete, were distributed.

Moderate risk, FDA, Blood donor screening

2 recalls

Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops

Clear Eyes Redness Relief eye drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

HCSC-Blood Center Plasma and Red Blood Cells

PF24 Plasma and Red Blood Cells, Leukocytes Reduced, with or without irradiation, were distributed after incomplete donor screening.

Moderate risk, FDA, Blood donor screening

17 recalls

Macleods Olanzapine Tablets

Olanzapine Tablets, USP 5 mg, failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

Amneal Exenatide Injection

Exenatide Injection prefilled pens may contain no medication due to a defective delivery system.

Moderate risk, FDA, Device defect

Penn State Health Holy Spirit Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed with incomplete testing.

Moderate risk, FDA, Quality testing problem

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor taking Proscar.

Moderate risk, FDA, Blood donor screening

American National Red Cross Red Blood Cells, Leukocytes Reduced, Irradiated

Red Blood Cells, Leukocytes Reduced, Irradiated were misbranded and distributed.

Moderate risk, FDA, Mislabeled product

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had taken Accutane.

Moderate risk, FDA, Blood donor screening

OneLegacy Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

Eversight Illinois Cornea

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

Moderate risk, FDA, Blood donor screening

OneLegacy Cornea

Corneas were distributed without adequate donor eligibility determination.

Moderate risk, FDA, Blood donor screening

San Antonio Eye Bank Cornea

A mislabeled cornea was distributed.

Moderate risk, FDA, Labeling error

South Dakota Lions Eye Bank Cornea

Corneas were distributed from a donor not adequately tested for communicable diseases.

Low risk, FDA, Quality testing problem

Lions Eye Bank Of Nebraska Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Blood donor screening

Tissue Transplant Technology Bone

Bone products could cause contamination or spread of disease.

Moderate risk, FDA, Contamination

American Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but came from a donor who tested positive.

Moderate risk, FDA, Labeling error

ImpactLife Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

Moderate risk, FDA, Quality testing problem

American National Red Cross Apheresis Platelets and Red Blood Cells

Apheresis Platelets and Red Blood Cells were out of monitored storage for an extended period.

Low risk, FDA, Processing problem

Carter BloodCare Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were leukoreduced by filtration at an unacceptable temperature.

Low risk, FDA, Processing problem

22 recalls

Niwali Tejocote Capsules and Niwali Tejocote Pieces

Niwali Tejocote Capsules and Pieces contain yellow oleander, which can cause severe or fatal health effects.

FDA