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Drug recalls

Drug recalls from FDA, newest first.
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7 recalls

Vitalant Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were collected with a potential for air contamination.

Moderate risk, FDA, Contamination

Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, Quality testing problem

5 recalls

CareFusion 213 BD ChloraPrep and PurPrep Applicators

BD ChloraPrep and PurPrep applicators may be unsterile or contaminated with fungus, potentially causing serious infection or death.

Moderate risk, FDA, Sterility problem

Accord BioPharma Imuldosa Injection

Imuldosa injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Medic Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were not tested for hemoglobin and residual white blood cell count as required.

Moderate risk, FDA, Quality testing problem

OneBlood Apheresis Red Blood Cells

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

Moderate risk, FDA, Quality testing problem

West TN Regional Blood Center Platelets, Pathogen Reduced

Platelets, Pathogen Reduced were distributed without pH testing.

Moderate risk, FDA, Quality testing problem

5 recalls

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

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, Quality testing problem

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, Labeling error

Mississippi Blood Services Apheresis and Red Blood Cells

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

Moderate risk, FDA, Quality testing problem

4 recalls

Povi-One, 10% Povidone-Iodine Oral Antiseptic

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

Moderate risk, FDA, Wrong drug strength

Mississippi Blood Services Apheresis Platelets and Red Blood Cells

Apheresis Red Blood Cells and Apheresis Platelets were labeled as leukocytes reduced but were not tested to verify the residual white blood cell count.

Moderate risk, FDA, 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, Quality testing problem

ARUP Laboratories Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were distributed without pH testing.

Moderate risk, FDA, Quality testing problem

9 recalls

Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags

The Total Parental Nutrition bag lacks copper and famotidine as labeled.

Moderate risk, FDA, Labeling error

Sun Pharmaceutical Perampanel CIII Tablets

Perampanel CIII Tablets, 6mg, may contain a 10mg tablet due to a label mix-up.

Moderate risk, FDA, Labeling error

Camber Lacosamide Tablets

Lacosamide Tablets may contain a foreign tablet, Selexipag 1000 mcg.

Moderate risk, FDA, Foreign object

ANI Pharmaceuticals Hydroxyzine Hydrochloride Oral Solution

HydrOXYzine Hydrochloride Oral Solution contains a foreign substance.

Low risk, FDA, Foreign object

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

New York Blood Center Fresh Frozen Plasma and Red Blood Cells

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

Moderate risk, FDA, Blood donor screening

Kentucky Blood Center Red Blood Cells, Leukocytes Reduced

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

Low risk, FDA, Processing problem

Vitalant Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

Abbott Determine HIV 1/2 Ag/Ab Combo

Abbott Diagnostics has noticed a negative trend in false positive complaints for Determine" HIV 1/2 Ag/Ab Combo 25T kits (Catalog 7D2648).

Moderate risk, FDA

5 recalls

Direct Rx Duloxetine and Cymbalta Capsules

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

Moderate risk, FDA, Drug impurity

Amgen Corlanor and Sensipar Tablets

Corlanor (ivabradine) tablets contain a foreign substance, and Sensipar (cinacalcet) Tablets have CGMP deviations.

Moderate risk, FDA, Foreign object

Medic Apheresis Platelets, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, 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, Quality testing problem

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

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

Moderate risk, FDA, Blood donor screening

5 recalls

Major Methylergonovine Maleate Tablets

Methylergonovine Maleate Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

Ajanta Pharma Fenofibrate Capsules

Fenofibrate Capsules, USP 200 mg, have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Blood Bank of Hawaii Apheresis Red Blood Cells, Pooled Cryoprecipitated AHF and Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, collected from a donor who had a hepatitis exposure prior to donation, were distributed.

Moderate risk, FDA, Contamination

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed after testing non-reactive for anti-HCV but from a donor who previously tested repeatedly reactive.

Moderate risk, FDA, Blood donor screening

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

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

Moderate risk, FDA, Blood donor screening

3 recalls

Keystone Topical Anesthetic Gels

Topical anesthetic gels may have defective containers with incomplete seals.

Moderate risk, FDA, Packaging defect

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had no hematocrit check performed during screening.

Moderate risk, FDA, Blood donor screening

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Blood donor screening

3 recalls

Endo Buprenorphine HCl Injection

Buprenorphine HCl injection has crystallization identified as Buprenorphine free base.

Moderate risk, FDA, Quality problem

Department of Air Force Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who answered "no" to reading educational materials.

Low risk, FDA, Blood donor screening

2 recalls

We Are Blood Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had taken aspirin within 72 hours of donation.

Moderate risk, FDA, Blood donor screening

Community Blood Center of the Ozarks Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to an area designated as endemic for malaria.

Moderate risk, FDA, Blood donor screening

5 recalls

Ajanta Pharma Aripiprazole Tablets

Aripiprazole Tablets USP are mislabeled, containing Voriconazole Tablets instead.

Moderate risk, FDA, Labeling error

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to an area designated as endemic for malaria.

Moderate risk, FDA, Blood donor screening

Coastal Bend 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, Blood donor screening

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Blood donor screening

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Blood donor screening

6 recalls

Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments

Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Inventia Healthcare Chlorthalidone Tablets

Chlorthalidone Tablets fail dissolution specifications.

Moderate risk, FDA, Drug dissolving problem