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Drug recalls

Drug recalls from FDA, newest first.
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3 recalls

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were prepared from whole blood that exceeded the acceptable collection volume.

Low risk, FDA, Quality testing problem

4 recalls

Tyenne (Tocilizumab-Aazg) Injection

Tyenne (tocilizumab-aazg) Injection contains glass particles that can cause irritation, swelling, vein inflammation, blood clots, and organ damage.

High risk, FDA, Foreign object

Avet Pharmaceuticals Clindamycin Palmitate Hydrochloride for Oral Solution

Clindamycin palmitate hydrochloride oral solution contains particles and white flakes in reconstituted bottles.

Moderate risk, FDA, Foreign object

Hoxworth 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

LifeShare 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

6 recalls

Novartis Diovan Tablets

Diovan (valsartan) 160 mg tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Apollo Care Semaglutide Injection Vials

Semaglutide sterile multi-dose vials contain particulate matter identified as nylon/polyamide and silk/proteinaceous-type material.

Moderate risk, FDA, Foreign object

Suncoast Communities Blood Bank Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had recently traveled to a malaria endemic area.

Moderate risk, FDA, Blood donor screening

Blood Assurance Pooled Cryoprecipitated AHF and Red Blood Cells

Pooled Cryoprecipitated AHF and Red Blood Cells, Leukocytes Reduced were collected from a donor at increased risk for Creutzfeldt-Jakob Disease.

Moderate risk, FDA, Blood donor screening

LifeSouth Community Blood Centers Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated were distributed without required testing.

Moderate risk, FDA, Quality testing problem

The Blood Connection Apheresis Platelets, Leukocytes Reduced

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

Low risk, FDA, Processing problem

1 recall

Zydus Mirabegron Extended-Release Tablets

Mirabegron Extended-Release Tablets contain an impurity above specification.

Moderate risk, FDA, Drug impurity

4 recalls

Victory Medical Center Pharmacy Glutathione Injection

Compounded glutathione vials have elevated bacterial endotoxin levels, which could cause fever, hypotension, inflammatory reactions, anaphylactic shock.

High risk, FDA, Sterility problem

Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags

Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag has an incorrect product formulation.

Low risk, FDA, Quality problem

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor in a malaria endemic area.

Moderate risk, FDA, Blood donor screening

American Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were distributed without platelet yield testing.

Low risk, FDA, Quality testing problem

4 recalls

Fresenius Kabi Morphine Sulfate Injection

Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

High risk, FDA, Labeling error

Aurobindo Pharma Dicyclomine Hydrochloride Capsules

Dicyclomine Hydrochloride Capsules are shortfilled, with reports of empty capsules.

Moderate risk, FDA, Quality problem

American National Red Cross Apheresis Platelets, PAS, Leukocytes Reduced

Apheresis Platelets, PAS, Leukocytes Reduced were distributed without quality control testing.

Moderate risk, FDA, Quality testing problem

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced failed a monthly QC residual white blood cell count.

Moderate risk, FDA, Labeling error

2 recalls

American Red Cross 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

American Red Cross Blood Services Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from donors who provided travel history to a malaria endemic area but were not assessed for residency.

Moderate risk, FDA, Blood donor screening

3 recalls

Adequan Canine and Equine Injections

Adequan Canine and Adequan i.m. injections contain glass fibers that may cause irritation, swelling, or infection.

Moderate risk, FDA, Contamination

Optiray Imaging Bulk Package-350, Ioversol Injection 74%

Optiray Imaging Bulk Package-350 contains particulate matter including plastic and glass, which may cause local irritation or swelling.

High risk, FDA, Foreign object

Parnell Sevoflurane Inhalation Anesthetic for Dogs

Sevoflurane inhalation solution has a bottle collar notch pattern incompatible with the sevoflurane-specific anti-spill pour spout.

FDA

1 recall

Glenmark Azelaic Acid Gel

Azelaic Acid Gel, 15%, 50 gram tubes may have abnormal texture or consistency described as grainy, gritty, or sandy.

Moderate risk, FDA, Manufacturing problem

9 recalls

Long Grove Pharmaceuticals Cyclophosphamide for Injection

Cyclophosphamide for Injection contains stainless steel particulate matter that can cause serious adverse events, including death.

High risk, FDA, Foreign object

Baxter Cefazolin in Dextrose Injection

Cefazolin in Dextrose Injection may contain particulate matter, which can cause pulmonary emboli, blood vessel occlusions, and phlebitis.

High risk, FDA, Foreign object

American Regent Nitroglycerin, Cyanocobalamin, Aminocaproic Acid, Atropine Sulfate, Acetylcysteine, Selenious Acid, Multrys, Papaverine HCl, Tralement and Nicardipine Injections

American Regent injections contain particulate matter.

High risk, FDA, Contamination

Micro Labs Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution has defective container caps that may break.

Moderate risk, FDA, Packaging defect

Proin ER, Phenylpropanolamine Hydrochloride Extended-Release Tablets

Proin ER tablets failed dissolution specifications, which can affect drug release.

Moderate risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran Etexilate Capsules failed impurity and degradation specifications.

Low risk, FDA, Drug impurity

Mylan Mycophenolate Mofetil for Injection

Mycophenolate Mofetil for Injection USP contains a precipitate.

Moderate risk, FDA, Quality problem

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced failed the monthly QC residual white blood cell count.

Moderate risk, FDA, Labeling error

Octapharma Octagam Immune Globulin (Human)

There is the potential for damaged units being on the US market.

Moderate risk, FDA

3 recalls

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections contain particulate matter.

Moderate risk, FDA, Foreign object

Rohto Cooling Eye Drops

Rohto Cooling Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Precision Dose Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution failed impurities and degradation specifications due to an unidentified impurity.

Moderate risk, FDA, Drug impurity

1 recall

AXP Processing Bag Set

AXP Processing Bag Set may release particulates into the sterile fluid path.

Moderate risk, FDA, Foreign object

4 recalls

Enovachem Pharmaceuticals Lidolog Kit

The Lidolog Kit has a label that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

We Are Blood Red Blood Cells and Pooled Cryoprecipitated AHF

Red Blood Cells, Leukocytes Reduced, collected from a donor who had permanent make-up applied within three months of donation, were distributed.

Moderate risk, FDA, Blood donor screening

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

Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced lack proper documentation of antigen typing.

Moderate risk, FDA

1 recall

Rising Pharma Cetirizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets may be contaminated with ranitidine, which could cause serious reactions.

High risk, FDA, Contamination

9 recalls

Rising Cyproheptadine Hydrochloride Syrup

Cyproheptadine Hydrochloride Syrup has crystallized and particles floating in the bottle.

Moderate risk, FDA, Foreign object

Major Pharmaceuticals Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Amlodipine and Olmesartan Medoxomil Tablets failed dissolution specifications, with Olmesartan Medoxomil content below specifications.

Moderate risk, FDA, Drug dissolving problem

Trokendi XR, Topiramate Extended-Release Capsules

Trokendi XR, topiramate extended-release capsules failed dissolution specifications.

Low risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran etexilate capsules failed impurity and degradation specifications during stability testing.

Low risk, FDA, Drug impurity

Bionpharma Divalproex Sodium Delayed-Release Tablets

Divalproex Sodium Delayed-Release Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object