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Drug recalls

Drug recalls from FDA, newest first.
Agency
Risk level
Date
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3 recalls

American Regent Epinephrine Injection

Presence of Particulate Matter and Lack of Assurance of Sterility.

High risk, FDA, Sterility problem

Trokendi XR (Topiramate) Extended-Release Capsules

Trokendi XR extended-release capsules failed dissolution specifications.

Low risk, FDA, Drug dissolving problem

Mylan Mycophenolate Mofetil for Injection

Mycophenolate Mofetil for injection fails dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

2 recalls

Teva Trazodone Hydrochloride Tablets

TraZODone Hydrochloride Tablets contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Vitalant Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

Moderate risk, FDA, Quality testing problem

2 recalls

Broadway Joe's Pain Cream

Broadway Joe's Pain Cream may be contaminated due to raw material issues.

Moderate risk, FDA, Contamination

Sage Chlorhexidine Gluconate Cloths

The 2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths may cause cross contamination with other products.

Moderate risk, FDA, Contamination

4 recalls

Lipofit Extreme Fat Burner 2.0

Lipofit Extreme Fat Burner 2.0 contains undeclared fluoxetine and DNP, which can cause serious and life-threatening effects.

FDA

American Health Packaging Buprenorphine Sublingual Tablets

Buprenorphine Sublingual Tablets have a labeling mix-up.

Low risk, FDA, Labeling error

New York Blood Center Apheresis Platelets, Leukocytes Reduced, Irradiated

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

Moderate risk, FDA, Quality testing problem

New York Blood Center Apheresis Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated were possibly manufactured with an incorrect ratio of blood to anticoagulant.

Low risk, FDA, Blood donor screening

9 recalls

GSMS Prasugrel HCI Tablets

Prasugrel tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Revcovi (Elapegademase-Lvlr) Injection

Revcovi injection failed stability specifications for protein concentration profile.

Low risk, FDA, Quality testing problem

Mylan Prasugrel Tablets

Prasugrel Tablets, USP, 10mg failed dissolution specifications and stability testing.

Moderate risk, FDA, Drug dissolving problem

The One SPF 50 Invisible Sunscreen Gel

THE ONE SPF 50 INVISIBLE SUNSCREEN GEL may not reliably provide the SPF 50 protection stated on the label.

Moderate risk, FDA, Wrong drug strength

Bionpharma Doxylamine Succinate and Pyridoxine HCl Delayed-Release Tablets 10 mg/10 mg

Doxylamine Succinate and Pyridoxine HCl tablets may contain foreign tablets or capsules.

Low risk, FDA, Foreign object

Baxter Vancomycin, Insulin, Daptomycin and Other Injections

Vancomycin Injection, USP in 5% Dextrose has CGMP deviations.

Moderate risk, FDA, Manufacturing problem

American National Red Cross Blood Services Apheresis Platelets

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

Moderate risk, FDA, Quality testing problem

Vitalant Apheresis Platelets, Leukocytes Reduced

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

Moderate risk, FDA, Quality testing problem

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

Red Blood Cells, Leukocytes Reduced, Irradiated may have been prepared incorrectly.

Moderate risk, FDA

2 recalls

B. Braun 0.9% Sodium Chloride Injection

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

High risk, FDA, Foreign object

Apotex Paxil CR, Paroxetine, Extended-Release Tablets

Paxil CR tablets failed dissolution specifications and stability testing acceptance criteria.

Moderate risk, FDA, Drug dissolving problem

4 recalls

Exelan Pharmaceuticals Ramipril Capsules USP

Ramipril Capsules USP, 10 mg, failed impurity specifications.

Moderate risk, FDA, Drug impurity

Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus

Zicam Cold Remedy Medicated Nasal Swabs have out of limit results for microbiological testing.

Moderate risk, FDA, Manufacturing problem

Acthar Gel (Repository Corticotropin Injection)

Acthar Gel contains particulate matter, glass and stopper piece.

Moderate risk, FDA, Foreign object

Lupin Clobetasol Propionate Cream

Clobetasol Propionate Cream USP, 0.05%, 60 g tube failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

4 recalls

Baxter Dextrose Injection

Dextrose Injection contains stainless steel particles that may cause serious health consequences.

High risk, FDA, Foreign object

Baxter 0.9% Sodium Chloride Injection

0.9% Sodium Chloride Injection contains fiberglass particulate matter that may cause serious health consequences.

High risk, FDA, Foreign object

Baxter Anticoagulant Sodium Citrate Solution

Anticoagulant Sodium Citrate Solution may contain fiberglass particles that can cause adverse health consequences.

High risk, FDA, Foreign object

Safecor Health Ibuprofen Oral Suspension

Ibuprofen oral suspension in syringes may be cross-contaminated with other products.

FDA, Contamination

1 recall

Whitebridge Pet Brands Remedy Recovery Dogswell Pet Wormer

This recall has been initiated out of an abundance of caution, due to complaints related to adverse events after administration of Remedy+ Recovery Dogswell Pet Wormer.

Moderate risk, FDA

2 recalls

Vitruvias Therapeutics Thyroid Tablets

Thyroid Tablets, USP are superpotent and can cause hyperthyroidism.

High risk, FDA, Wrong drug strength

Accord Healthcare Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

5 recalls

B. Braun Lactated Ringer's Injection

Presence of Particulate matter.

High risk, FDA, Foreign object

Optimal Balance Pharmacy Glutathione Injection

Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.

High risk, FDA, Sterility problem

Golden State Medical Supply Carbamazepine Tablets

Carbamazepine Tablets, USP, 200mg have black specks due to CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Mylan Acamprosate Calcium, Delayed-Release Tablets

Acamprosate Calcium, Delayed-Release Tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Suncoast Communities Blood Bank Red Blood Cells and Whole Blood

Red Blood Cells and Whole Blood were distributed from donors with incomplete eligibility screening.

Moderate risk, FDA, Blood donor screening

3 recalls

Taro Carbamazepine Tablets

Carbamazepine tablets may contain black specks from burnt excipient during manufacturing.

Moderate risk, FDA, Quality problem

OneBlood Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a therapeutic donor incorrectly registered as allogeneic.

Moderate risk, FDA, Blood donor screening

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

Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced, for which platelet yield did not meet specifications, were distributed.

Moderate risk, FDA, Quality testing problem

2 recalls

Amneal PEMRYDI RTU (Pemetrexed Injection)

PEMRYDI RTU (pemetrexed injection) has a discolored solution, which can be green to dark green.

Moderate risk, FDA, Quality problem

Libtayo (Cemiplimab-Rwlc) Injection

Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

5 recalls

Shoolin Pharma Chem Sildenafil Citrate and Tadalafil

Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.

Moderate risk, FDA, Manufacturing problem

CLEAR EYES Maximum Itchy Eye Relief

CLEAR EYES Maximum Itchy Eye Relief lacks assurance of sterility and may be contaminated.

Moderate risk, FDA, Sterility problem

New York Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor previously deferred for hepatitis C antibody testing.

Moderate risk, FDA, Contamination

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

Walter L. Shepeard Community 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

3 recalls

LifeShare Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed after incomplete donor eligibility screening.

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