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Drug recalls

Drug recalls from FDA, newest first.
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4 recalls

Xiamen Kang Zhongyuan Biotechnology Cough Drops and Throat Soothing Drops

Cough drops may have quality problems that could affect product quality.

Moderate risk, FDA, Manufacturing problem

2 recalls

GE Healthcare Omnipaque (Iohexol) Injection

GE Healthcare Omnipaque (iohexol) Injection contains particulate matter.

Moderate risk, FDA, Foreign object

Huvepharma Amprol 25% Type A Medicated Article

Amprol 25% (amprolium) Type A medicated article is missing its lot number and expiration date on one bag.

Low risk, FDA, Labeling error

3 recalls

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions

Blaine Labs Wound Care Gels and Antifungal Creams and Solutions have manufacturing deviations or bacterial contamination.

High risk, FDA, Contamination

Viatris Xanax XR Extended-Release Tablets

Xanax XR extended-release tablets failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Teva Isotretinoin Capsules

Isotretinoin capsules are superpotent and subpotent.

Moderate risk, FDA, Wrong drug strength

2 recalls

Fagron Norepinephrine and Vancomycin Injections

Norepinephrine Bitartrate and Vancomycin injections lack assurance of sterility, and a blue part could detach from the port.

Moderate risk, FDA, Sterility problem

Preferred Pharmaceuticals Artificial Tears Lubricant Eye Drops

Artificial Tears Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

2 recalls

Fresenius Kabi Sodium Chloride and Dextrose Injections

Sodium chloride and dextrose injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Cipla Lanreotide Injection

Lanreotide Injection lacks assurance of sterility due to deficiencies in visual inspection.

Moderate risk, FDA, Sterility problem

3 recalls

Biocon Prazosin Hydrochloride Capsules

Prazosin Hydrochloride Capsules contain a nitrosamine impurity above acceptable limits.

Moderate risk, FDA, Drug impurity

K.C. Pharmaceuticals Eye Drops

Sterile eye drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

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

2 recalls

Kian Pee Wan Capsules

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

High risk, FDA, Hidden drug ingredient

Amneal Tramadol Hydrochloride Tablets

TraMADol Hydrochloride Tablets contain an impurity that failed specifications.

Moderate risk, FDA, Drug impurity

2 recalls

Chiesi Curosurf Intratracheal Suspension

Curosurf (poractant alfa) lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed without a visual inspection.

Low risk, FDA, Quality testing 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

5 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

Biomedical Data Solutions Complete Ortho Connect 3.x Software

Complete Ortho Connect 3.x Software has an issue with check rules that could lead to an incorrect result being reported or submitted for a patient.

Moderate risk, FDA, Software defect

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

2 recalls

Somerset Therapeutics Dexamethasone Sodium Phosphate Injection

Dexamethasone Sodium Phosphate Injection failed impurity specifications.

Moderate risk, FDA, Drug impurity

Norbrook Noromycin 300 LA Oxytetracycline Injection

Noromycin 300 LA antibiotic lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

4 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

Northstar Rx Pitavastatin Tablets

Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg.

Low risk, FDA, Foreign object

1 recall

Pure Vitamins and Natural Supplements Male Enhancement Supplements

Pure Vitamins and Natural Supplements Male Enhancement Supplements contain sildenafil.

High risk, FDA, Hidden drug ingredient

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

1 recall

Huvepharma BioCox 60 Type A Medicated Article

BioCox 60 failed to meet stability specification requirements for assay.

Moderate risk, FDA, Quality testing problem

4 recalls

Nomida Semaglutide and Tirzepatide Injections

Semaglutide and tirzepatide injections lack assurance of sterility.

Moderate risk, FDA, Sterility problem

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

MR. 7 Super 700000 Capsules

Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of 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