Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
All Recalls
95,018 total recalls in our database
Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Sterile Prefilled Syringe 0.5 mL, For Subcutaneous Use, Rx Only, Sterile, Distributor: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054, USA, NDC 55566-1010-1
Sun Pharmaceutical Industries
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Doxazosin Tablets, USP, 4mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-109-52
Northwind Pharmaceuticals
CGMP Deviations
CBD Metered Dose Inhaler (CBD) 5 mg Dose, 1 Metered Dose Inhaler, 100 Metered Sprays, Wellness BioSciences Rx
Wellness BioSciences
Marketed Without an Approved NDA/ANDA
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203. NDC 51655-487-52
Northwind Pharmaceuticals
CGMP Deviations
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Northwind Pharmaceuticals
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose Container, SCA Pharmaceuticals, Windsor, CT 06095, NDC# 70004-085-44
SCA Pharmaceuticals
Subpotent Drug: Out of specification results for low potency was obtained.
Sterile surgical convenience kit: regard Item Number 800706005, LD0091E - OH C-Section Pack.
ROi CPS
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
HAMILTON-C6, REF: 160021
Hamilton Medical AG
Software error causes, safety ventilation, in which ventilation continues in the "safety ventilation" mode with audible/visible alarm - patient inputs are not monitored, if the following coincide 1) A mode change to an adaptive mode (ASV, APVcmv, APVsimv, INTELLiVENT-ASV, (S)CMV+, SIMV+), and 2) The controller and/or humidifier is connected to the ventilator and is operational.
The power cord supplied (Type J plug end) for the Cardiosave Hybrid IABP to Brazil is incompatible with the Brazilian Type N power receptacle.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Mani Trocar Kit, Model MTK23S and Model MTK25S There are 3 kits contained in one box, and sterile 1 kit consists of 3 pcs. trocar with the valved cannula and 1 pc. infusion cannula.
Mani, Inc. - Kiyohara Facility
A packaging defect may compromise the sterile barrier.
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
Wright Medical Technology
Two lots of Ortholoc 3Di Fusion plates contain incorrect dorsiflexion descriptions laser marked on the parts.
FLEX. BIOPSY FORCEPS 5FR WL 550MM, Product Number 829.051
Richard Wolf GmbH
Potentially unable to open forceps jaws when the endoscope shaft is bent by about 90 degrees. If, in addition, the proximal forceps shaft is bent, the forceps can no longer be opened or restrictions begin even with a slight bending of the endoscope.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.