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Drug recalls

Drug recalls from FDA, newest first.
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3 recalls

Alembic Pharmaceuticals Bromfenac Ophthalmic Solution 0.07%

Bromfenac Ophthalmic Solution 0.07% failed impurities and degradation specifications at the 20th month stability testing.

Moderate risk, FDA, Drug impurity

1 recall

Amneal Tramadol Hydrochloride Tablets

TraMADol Hydrochloride Tablets contain an impurity that failed specifications.

Moderate risk, FDA, Drug impurity

1 recall

Chiesi Curosurf Intratracheal Suspension

Curosurf (poractant alfa) lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

3 recalls

Gear Isle Chocolate

Chocolate products contain undeclared sildenafil and tadalafil, which may cause a significant drop in blood pressure.

FDA

Thermo Fisher Scientific TSCM17, TSCM34 and TSCM48 Laboratory Freezers

The CryoMed Controlled-Rate Freezer has a heater that may not meet factory specifications and could trip a circuit breaker or shock the user.

Moderate risk, FDA

American National Red Cross Cryoprecipitated AHF and Blood Components

Blood products including Cryoprecipitated AHF, PF24 Plasma, and Red Blood Cells may have had incorrect arm preparation.

Moderate risk, FDA

2 recalls

American Health Packaging Meclizine Hydrochloride Tablets

Meclizine Hydrochloride Tablets failed tablet specifications.

Moderate risk, FDA, Quality testing problem

Ortho-Clinical Diagnostics ORTHO VISION and ORTHO VISION Max Analyzers

Quidel Ortho is recalling the Ortho Vision and Ortho Vision Max Analyzers for ID-Micro Typing System (MTS) Gel Cards Software Version 5.16 and below for a software anomaly where the analyzer is unable to perform inventory of loaded reagents if the loading station door is opened immediately after the allotted 20-second countdown ends but within 0.2 seconds before to the door re-locks.

Moderate risk, FDA, Software defect

4 recalls

Amneal Pharmaceuticals Magnesium Sulfate in Water for Injection

Magnesium Sulfate in Water for Injection IV bags may contain Tranexamic Acid instead, which can cause blood clotting, seizures, and other adverse events.

High risk, FDA, Labeling error

Teva Octreotide Acetate for Injectable Suspension

Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.

Moderate risk, FDA, Sterility problem

MacLeods Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets are subpotent.

Moderate risk, FDA, Wrong drug strength

WellSky Transfusion Blood-Bank Management System

The blood-bank management system can fail to present a required alert, which could permit transfusion of incompatible blood.

Moderate risk, FDA, Software defect

1 recall

American National Red Cross Blood Components

American National Red Cross Blood Components, collected in a manner that compromises the sterility of the collection system, were distributed.

Moderate risk, FDA, Sterility problem

1 recall

International Isotopes Gelatin Capsule Pack for Sodium Iodide I-131 Kit

The Gelatin Capsule Pack failed tablet or capsule specifications.

Low risk, FDA, Quality testing problem

1 recall

Somerset Therapeutics Dexamethasone Sodium Phosphate Injection

Dexamethasone Sodium Phosphate Injection failed impurity specifications.

Moderate risk, FDA, Drug impurity

3 recalls

Apotex Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution

Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Taro Children's Ibuprofen Oral Suspension

Children's Ibuprofen Oral Suspension contains a gel-like mass and black particles.

Moderate risk, FDA, Foreign object

Cardinal Health Webcol Alcohol Prep Pads

Webcol Alcohol Prep pads may be non-sterile due to microbial contamination, posing an infection risk to vulnerable groups.

High risk, FDA, Sterility problem

1 recall

Winder Laboratories Multivitamin with Fluoride Chewable Tablets

Multivitamin with Fluoride Chewable Tablets are subpotent for Vitamin D.

Low risk, FDA, Wrong drug strength

1 recall

Zydus Pharmaceuticals Icosapent Ethyl Capsules

Icosapent Ethyl Capsules have red dots inside and melted capsules due to oxidized active ingredient.

Moderate risk, FDA, Quality testing problem

2 recalls

Radnostix Sodium Iodide I-131 Oral Solution

Sodium Iodide (I-131) Solution contains particulate matter due to production issues.

Moderate risk, FDA, Foreign object

Mohamed Hagar Mojo Max Fusion XXX Capsules

Mojo Max Fusion XXX contains undeclared sildenafil and tadalafil.

High risk, FDA, Hidden drug ingredient

3 recalls

Rising Pharmaceuticals Temozolomide Capsules, 5mg

Temozolomide Capsules failed impurities and degradation specifications during stability testing.

Moderate risk, FDA, Drug impurity

Dermal Source Five-Star Vasocaine Spray and Maximum Zone Lidocaine Creams

Stability Data Does Not Support Expiry Date.

Moderate risk, FDA, Quality testing problem

Mylan Amnesteem Isotretinoin Capsules

Amnesteem (Isotretinoin) Capsules, USP 40 mg failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

2 recalls

Cipla Nilotinib Capsules

Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.

Low risk, FDA, Quality testing problem

Major Pharmaceuticals Midodrine Hydrochloride Tablets

Midodrine Hydrochloride Tablets have defective containers and inadequately sealed blister packaging.

Moderate risk, FDA, Packaging defect

2 recalls

Acme United BZK Antiseptic Towelettes and Hand Sanitizing Wipes

BZK Antiseptic Towelettes have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Harbin Jixianglong Biotech Semaglutide

Harbin Jixianglong Biotech Semaglutide failed to complete process validation and bacterial endotoxin method validation before distribution.

Moderate risk, FDA, Manufacturing problem

1 recall

Teva Metoprolol Succinate Extended-Release Tablets

Metoprolol Succinate Extended-Release Tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

3 recalls

Lockout Supplements Boner Bears Chocolate Syrup

Boner Bears Chocolate Syrup contains undeclared sildenafil, which may lower blood pressure to dangerous levels.

FDA

Agebox iKids-Growth Day and Night Formula Capsules

Agebox iKids-Growth (Day Formula) capsules contain undeclared ibutamoren.

Moderate risk, FDA, Hidden drug ingredient

Wizcure Pharmaa Eye Drops and Fluorescein Sodium Ophthalmic Strips

Vista Tears, Vista Gel, Vista Meibo Tears, Vista Gonio, CHNaO, Bio Glo, and BioGlo eye products lack assurance of sterility.

Moderate risk, FDA, Sterility problem

3 recalls

Slate Run Eptifibatide Injection

Eptifibatide Injection's carton labeling states 75 mg/100 mL vial for weight-adjusted bolus dosing, but the approved statement is for weight-adjusted infusion.

Low risk, FDA, Labeling error

AvKARE Amantadine HCl Capsules

Amantadine HCl capsules failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Adbry (Tralokinumab-Ldrm) Injection

Adbry injection may not be sterile due to wool fiber particulate matter in one unit.

Moderate risk, FDA, Sterility problem

1 recall

Fresenius Kabi Acyclovir, Ketamine, Thiamine and Vancomycin Injections

Acyclovir sodium, ketamine HCl, thiamine HCl, and vancomycin HCl injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

4 recalls

Asteria Health Estradiol and Testosterone Sterile Pellets

Estradiol and testosterone sterile pellets may contain metal particulate matter.

Moderate risk, FDA, Foreign object

Unichem Doxazosin Tablets

Doxazosin Tablets, USP, 4 mg are imprinted with the wrong ID.

Low risk, FDA, Labeling error

Meitheal Pharmaceuticals Cetrorelix Acetate for Injection (Kit)

Cetrorelix Acetate for Injection kits may have missing or duplicated needles.

Moderate risk, FDA, Device defect

American Red Cross Apheresis Platelets and Red Blood Cells

American Red Cross Apheresis Platelets and Red Blood Cells, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Quality testing problem

3 recalls

Accord BioPharma Udenyca Prefilled Syringe

Udenyca injection was stored at room temperature instead of refrigerated.

High risk, FDA, Processing problem

American Health Packaging Oxycodone Hydrochloride Tablets

Oxycodone Hydrochloride Tablets have defective card seals, which can cause tablets to come out of their cavities.

Moderate risk, FDA, Packaging defect

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

American National Red Cross - Johnstown, PA products, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Quality testing problem

1 recall

Pro Numb Tattoo Numbing Spray

Pro Numb Tattoo Numbing Spray is recalling its Pro Numb Tattoo Numbing Spray because of cGMP deviations.

Moderate risk, FDA, Manufacturing problem

1 recall

American National Red Cross Red Blood Cells

American National Red Cross Red Blood Cells, for which Babesia testing was not performed, were distributed.

Moderate risk, FDA, Quality testing problem

4 recalls

Taro Diclofenac Sodium Topical Gel 3%

Diclofenac Sodium Topical Gel 3% has a viscosity that is slightly lower than the limit.

Moderate risk, FDA, Quality testing problem

Granules Trazodone Hydrochloride Tablets

Trazodone Hydrochloride tablets contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Stratford Care: 36 products

Keto-C Antiseptic Wipes labeled as medicated contain a non-medicated otic flush due to a product mix-up.

Moderate risk, FDA, Labeling error

Green Lumber Natural Fuel For Men Capsules

Green Lumber Natural Fuel For Men capsule contains tadalafil without approval.

High risk, FDA, Hidden drug ingredient