Drug recalls
American Regent Epinephrine Injection
Presence of Particulate Matter and Lack of Assurance of Sterility.
Trokendi XR (Topiramate) Extended-Release Capsules
Trokendi XR extended-release capsules failed dissolution specifications.
Mylan Mycophenolate Mofetil for Injection
Mycophenolate Mofetil for injection fails dissolution specifications.
Teva Trazodone Hydrochloride Tablets
TraZODone Hydrochloride Tablets contain foreign tablets or capsules.
Vitalant Pooled Cryoprecipitated AHF
Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.
Broadway Joe's Pain Cream
Broadway Joe's Pain Cream may be contaminated due to raw material issues.
2 productsSage Chlorhexidine Gluconate Cloths
The 2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths may cause cross contamination with other products.
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.
American Health Packaging Buprenorphine Sublingual Tablets
Buprenorphine Sublingual Tablets have a labeling mix-up.
New York Blood Center Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated had a platelet count higher than acceptable.
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.
GSMS Prasugrel HCI Tablets
Prasugrel tablets failed dissolution specifications.
Revcovi (Elapegademase-Lvlr) Injection
Revcovi injection failed stability specifications for protein concentration profile.
Mylan Prasugrel Tablets
Prasugrel Tablets, USP, 10mg failed dissolution specifications and stability testing.
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.
4 productsBionpharma Doxylamine Succinate and Pyridoxine HCl Delayed-Release Tablets 10 mg/10 mg
Doxylamine Succinate and Pyridoxine HCl tablets may contain foreign tablets or capsules.
Baxter Vancomycin, Insulin, Daptomycin and Other Injections
Vancomycin Injection, USP in 5% Dextrose has CGMP deviations.
17 productsAmerican National Red Cross Blood Services Apheresis Platelets
Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced were not tested for pH and were distributed.
Vitalant Apheresis Platelets, Leukocytes Reduced
Apheresis Platelets, Leukocytes Reduced were distributed with platelet yield that did not meet specifications.
American National Red Cross Red Blood Cells, Leukocytes Reduced, Irradiated
Red Blood Cells, Leukocytes Reduced, Irradiated may have been prepared incorrectly.
B. Braun 0.9% Sodium Chloride Injection
0.9% Sodium Chloride Injection contains particulate matter that can cause life-threatening health consequences.
Apotex Paxil CR, Paroxetine, Extended-Release Tablets
Paxil CR tablets failed dissolution specifications and stability testing acceptance criteria.
Exelan Pharmaceuticals Ramipril Capsules USP
Ramipril Capsules USP, 10 mg, failed impurity specifications.
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus
Zicam Cold Remedy Medicated Nasal Swabs have out of limit results for microbiological testing.
Acthar Gel (Repository Corticotropin Injection)
Acthar Gel contains particulate matter, glass and stopper piece.
Lupin Clobetasol Propionate Cream
Clobetasol Propionate Cream USP, 0.05%, 60 g tube failed content uniformity specifications.
Baxter Dextrose Injection
Dextrose Injection contains stainless steel particles that may cause serious health consequences.
Baxter 0.9% Sodium Chloride Injection
0.9% Sodium Chloride Injection contains fiberglass particulate matter that may cause serious health consequences.
Baxter Anticoagulant Sodium Citrate Solution
Anticoagulant Sodium Citrate Solution may contain fiberglass particles that can cause adverse health consequences.
Safecor Health Ibuprofen Oral Suspension
Ibuprofen oral suspension in syringes may be cross-contaminated with other products.
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.
Vitruvias Therapeutics Thyroid Tablets
Thyroid Tablets, USP are superpotent and can cause hyperthyroidism.
Accord Healthcare Levothyroxine Sodium Tablets
Levothyroxine Sodium Tablets are subpotent.
12 productsB. Braun Lactated Ringer's Injection
Presence of Particulate matter.
Optimal Balance Pharmacy Glutathione Injection
Glutathione 200 mg/mL sterile multidose vials have elevated bacterial endotoxin levels, which could cause significant medical events.
Golden State Medical Supply Carbamazepine Tablets
Carbamazepine Tablets, USP, 200mg have black specks due to CGMP deviations.
Mylan Acamprosate Calcium, Delayed-Release Tablets
Acamprosate Calcium, Delayed-Release Tablets failed dissolution specifications.
Suncoast Communities Blood Bank Red Blood Cells and Whole Blood
Red Blood Cells and Whole Blood were distributed from donors with incomplete eligibility screening.
2 productsTaro Carbamazepine Tablets
Carbamazepine tablets may contain black specks from burnt excipient during manufacturing.
OneBlood Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced were collected from a therapeutic donor incorrectly registered as allogeneic.
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.
Amneal PEMRYDI RTU (Pemetrexed Injection)
PEMRYDI RTU (pemetrexed injection) has a discolored solution, which can be green to dark green.
2 productsLibtayo (Cemiplimab-Rwlc) Injection
Libtayo (cemiplimab-rwlc) Injection lacks assurance of sterility.
Shoolin Pharma Chem Sildenafil Citrate and Tadalafil
Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.
5 productsCLEAR EYES Maximum Itchy Eye Relief
CLEAR EYES Maximum Itchy Eye Relief lacks assurance of sterility and may be contaminated.
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.
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.
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.
LifeShare Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced were distributed after incomplete donor eligibility 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.










































