ADAPTABLE Beach Chair Beach Chair Surgical Patient Positioner
The Adaptable Beach Chair surgical patient positioner has a manufacturing issue with an inadequate weld for the head positioning system.
Manufacturing deviation recalls
Recalls flagged for manufacturing deviation, newest first. 59 recalls
1 recall
1 recall
Custom Interventional Pain Management Mastisol Skin Adhesive and Continuous Epidural Trays
Mastisol Skin Adhesive has manufacturing issues with the liquid adhesive in surgical trays.
1 recall
Penumbra System (RED 62 Reperfusion Catheter)
The Penumbra System (RED 62 Reperfusion Catheter) may fracture due to manufacturing issues.
1 recall
NOxBOXi Nitric Oxide Delivery System
The NOxBOXi Nitric Oxide Delivery System may have irregular oxygen readings due to a manufacturing issue.
1 recall
Menow Sunscreen Pressed Powder SPF35 PA+++
MENOW SUNSCREEN PRESSED POWDER SPF35 PA+++ has cGMP deviations.
1 recall
Dechra Veterinary Products Puralube Vet Ointment
Puralube Vet Ointment has cGMP deviations.
1 recall
Baxter Vancomycin, Insulin, Daptomycin and Other Injections
Vancomycin Injection, USP in 5% Dextrose has CGMP deviations.
17 products
1 recall
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus
Zicam Cold Remedy Medicated Nasal Swabs have out of limit results for microbiological testing.
1 recall
Hollister Onli Hydrophilic Urethral Intermittent Catheters
The Onli 17cm Hydrophilic Urethral Intermittent Catheter may have a protrusion that could cause genitourinary trauma or bleeding.
1 recall
Golden State Medical Supply Carbamazepine Tablets
Carbamazepine Tablets, USP, 200mg have black specks due to CGMP deviations.
1 recall
Shoolin Pharma Chem Sildenafil Citrate and Tadalafil
Sildenafil citrate and tadalafil USP have CGMP deviations noted during FDA inspection.
5 products
1 recall
Zydus Mirabegron Extended-Release Tablets
Mirabegron Extended-Release Tablets contain an impurity above specification.
1 recall
Glenmark Azelaic Acid Gel
Azelaic Acid Gel, 15%, 50 gram tubes may have abnormal texture or consistency described as grainy, gritty, or sandy.
1 recall
Penumbra System RED 68 Reperfusion Catheter
The Penumbra System RED 68 Reperfusion Catheter may fracture due to manufacturing issues.
1 recall
SeaSpine Polyaxial Head
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
2 recalls
Oscor Abiomed Impella Introducer Kits
The introducer kit for the Impella system may leak from the sidearm, under the sheath cap, and along hub score lines.
3 products
Abiomed Impella Heart Pumps and Introducer Kits
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.
13 products
1 recall
Somerset Therapeutics Pemetrexed, Bortezomib and Azacitidine for Injection
Pemetrexed, Bortezomib, and Azacitidine for Injection lack sterility assurance.
4 products
2 recalls
Shimoga Chemicals Clomiphene Citrate Active Pharmaceutical Ingredient
Clomiphene Citrate USP Active Pharmaceutical Ingredient has cGMP deviations.
ConvaTec Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
3 recalls
Cipla Cinacalcet Hydrochloride Tablets
CGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
3 products
Bard Catheters, Dialysis Catheters, and Biopsy Trays
The lidocaine ampoules in these devices were manufactured under deficient practices and are being recalled by the supplier.
14 products
Medtronic Harmony Delivery Catheter System
The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.
1 recall
Lupin Pharmaceuticals Glucagon Emergency Kit for Low Blood Sugar
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
3 products
1 recall
Synjardy XR Tablets (Empagliflozin and Metformin Hydrochloride Extended-Release Tablets)
An incorrect detergent was used and required swab sampling was not performed on a production hopper.
1 recall
Octopus 4, Evolution, and Evolution AS Tissue Stabilizer
The Octopus Evolution Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.
3 products
3 recalls
Direct Rx Duloxetine and Cymbalta Capsules
Duloxetine D/R contains an impurity above the FDA recommended interim limit.
Acumed Hexalobe Screws
Acumed Hexalob Screws may break during use due to a manufacturing error.
Amgen Corlanor and Sensipar Tablets
Corlanor (ivabradine) tablets contain a foreign substance, and Sensipar (cinacalcet) Tablets have CGMP deviations.
5 products
1 recall
Ajanta Pharma Fenofibrate Capsules
Fenofibrate Capsules, USP 200 mg, have CGMP deviations.
1 recall
Smith & Nephew Trigen Proximal Straight Humeral Nail
The humeral nail is missing distal holes and may lead to revision surgery if implanted.
1 recall
Dabur Antifungal, Antibiotic and Hydrocortisone Creams and Ointments
Reason given by FDA: CGMP Deviations; deficiencies observed during FDA inspection.
14 products
1 recall
Breckenridge Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended interim limit.
2 products
1 recall
Asclemed USA Duloxetine DR Capsules
Duloxetine DR Capsules contain a nitrosamine impurity above the acceptable limit.
1 recall
Zydus Erythromycin Tablets
Reason given by FDA: CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit.
2 products
1 recall
VitaminAlly Liquid Supplements
VitaminAlly Liquid Supplements have CGMP deviations and a possible C. botulinum (botulism) risk.
14 products
1 recall
Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the recommended limit.
1 recall
Ajanta Pharma Duloxetine Delayed-Release Capsules
Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.
3 products
1 recall
Spacelabs Ultraview SL Command Module
The Spacelabs Ultraview SL Command Module has a manufacturing issue with its electrical leakage tester.
1 recall
Abbott I-STAT EG7+, EG6+, and G3+ Cartridges
I-STAT cartridges may report higher PCO2 and lower pH results, appearing as severe respiratory acidosis.
3 products
2 recalls
iVIZIA Sterile Lubricant Eye Drops
IVIZIA Sterile Lubricant Eye Drops lack assurance of sterility due to manufacturing deviations.
2 products
Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions
Injectable solutions of phenylephrine, fentanyl, and ketamine have cGMP deviations.
7 products
1 recall
SurgiSmoke Solutions Flamingo Funnel
Flamingo Funnels were made with a non-gamma sterilization compatible drape.
3 products
1 recall
Leading Pharma Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
1 recall
Angiodynamics AccuVu and Soft-Vu Angiographic Catheter
A manufacturing defect may prevent the guidewire from passing through the catheter hub.
20 products
1 recall
Actavis Clonidine Transdermal System
Clonidine Transdermal System was made with an unapproved raw material.
3 products
1 recall
Cipla Cinacalcet Hydrochloride Tablets
Reason given by FDA: CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit.
3 products
1 recall
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.
8 products
1 recall
Biocon Prazosin Hydrochloride Capsules
Prazosin Hydrochloride Capsules contain a nitrosamine impurity above acceptable limits.
3 products
2 recalls
OrthAlign Lantern Knee System Drill Plates
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
2 products