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Drug recalls

Drug recalls from FDA, newest first.
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5 recalls

BD PurPrep Povidone-Iodine and Isopropyl Alcohol Antiseptic Solution

BD PurPrep sterile solution may lack assurance of sterility due to potential contamination.

Moderate risk, FDA, Sterility problem

Terumo BCT Rika Plasma Donation System

The Rika Plasma Donation System has a potential safety issue with an electrical component in a control valve.

Moderate risk, FDA

3 recalls

Fresenius Medical Care Delflex Peritoneal Dialysis Solution

Delflex, Dextrose Peritoneal Dialysis Solution may have leaks from perforations in bags, lacking assurance of sterility.

Moderate risk, FDA, Sterility problem

Ajanta Pharma Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.

Moderate risk, FDA, Drug impurity

Harrow Eye FreshKote Lubricant Eye Drops

Freshkote Lubricant Eyedrops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall

Unichem busPIRone Hydrochloride Tablets

BusPIRone Hydrochloride Tablets are subpotent.

Low risk, FDA, Wrong drug strength

1 recall

CVS Pharmacy Lidocaine Wound Gel

Lidocaine Wound Gel failed pH specifications.

Low risk, FDA, Quality testing problem

1 recall

Hikma Pharmaceuticals Alendronate Sodium Oral Solution

This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.

Moderate risk, FDA, Quality testing problem

5 recalls

B. Braun Lactated Ringer's Injection

Lactated Ringer's Injection may contain particulate matter that can cause patient harm.

High risk, FDA, Foreign object

Optase Dry Eye Intense Drops (Glycerin 0.2%)

Optase Dry Eye Intense Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

iVIZIA Sterile Lubricant Eye Drops

IVIZIA Sterile Lubricant Eye Drops lack assurance of sterility due to manufacturing deviations.

Moderate risk, FDA, Sterility problem

American Regent Levocarnitine Injection

Levocarnitine Injection is missing its label.

Low risk, FDA, Labeling error

Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions

Injectable solutions of phenylephrine, fentanyl, and ketamine have cGMP deviations.

Moderate risk, FDA, Manufacturing problem

1 recall

GenTeal Tears and Systane Lubricant Eye Gel

Systane Lubricant Eye Gel Night Gel may lack assurance of sterility.

Moderate risk, FDA, Sterility problem

1 recall

B. Braun Sterile Water, Dextrose, Sodium Chloride and Lactated Ringer's Injections and Irrigation

Sterile Water for Injection USP lacks assurance of sterility, which could cause leakage from the diaphragm port.

Moderate risk, FDA, Sterility problem

1 recall

Leading Pharma Furosemide Tablets

CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.

Moderate risk, FDA, Drug impurity

1 recall

Premier Monsel's Ferric Subsulfate Solution

Premier Monsel's Ferric Subsulfate Solution has an incorrect expiration date printed on the vial.

Low risk, FDA, Labeling error

3 recalls

Major Pharmaceuticals Omega-3-Acid Ethyl Esters Capsules

Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram failed capsule specifications for loss on drying of capsule shells.

Moderate risk, FDA, Quality testing problem

Teva Claravis Isotretinoin Capsules

Claravis (isotretinoin capsule, USP), 10 mg, failed impurities/degradation specifications for specific impurity Tretinoin.

Moderate risk, FDA, Drug impurity

Camber Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium tablets are discolored with lighter-colored spots.

Moderate risk, FDA, Quality problem

3 recalls

Skin Script Blemish Spot Treatment

Blemish Spot Treatment failed stability specifications.

Moderate risk, FDA, Quality testing problem

Apotex Desmopressin Nasal Spray

Desmopressin Nasal Spray has defective bottle caps with dislodged or missing liners.

Moderate risk, FDA, Packaging defect

Avantor Magnesium Chloride 6-Hydrate Crystal

Magnesium Chloride, 6-Hydrate, Crystal is subpotent.

Low risk, FDA, Wrong drug strength

4 recalls

International Medication Systems Epinephrine Injection

Epinephrine Injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Huons Lidocaine, Bupivacaine and Sodium Chloride Injections

Lidocaine HCl injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

CoValence Laboratories Hydrocortisone Gels and Balm

Remedy Gel, hydrocortisone 1%, is subpotent.

Low risk, FDA, Wrong drug strength

Nephron Albuterol Sulfate Inhalation Solution

Albuterol Sulfate Inhalation Solution has an illegible label.

Moderate risk, FDA, Labeling error

1 recall

Taro Fluocinonide Cream

Fluocinonide cream failed viscosity specifications.

Moderate risk, FDA, Quality testing problem

4 recalls

Major Pharmaceuticals Memantine Hydrochloride Extended-Release Capsules

Memantine Hydrochloride Extended-Release Capsules failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Owen Biosciences Benzoyl Peroxide Acne Treatments

Chemical contamination: Presence of benzene.

Moderate risk, FDA, Chemical contamination

Cipla Cinacalcet Hydrochloride Tablets

Cipla is recalling its Cipla Cinacalcet Hydrochloride Tablets because of CGMP deviations and presence N-Nitroso Cinacalcet above the acceptable daily intake limit.

Moderate risk, FDA, Drug impurity

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

2 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

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

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