Mylan Pharmaceuticals Fexofenadine HCl Tablets, USP, 180 mg recall — FDA D-0428-2019
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
Browse the newest complete recall records currently stored from FDA enforcement reports and NHTSA vehicle campaigns. “Latest” refers to the newest source-dated record in this database, not the timestamp of our last API check.
The newest recall records with useful source details are listed here.
Failed Impurities/Degradation Specifications: Related compound results obtained during routine stability testing was slightly elevated above specification.
CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an…
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level…
Subaru of America, Inc. (Subaru) is recalling certain 2019 Forester and Crosstrek vehicles. A connector inside the Electronic Power Steering (EPS) unit may short circuit resulting in a loss…
Chrysler (FCA US LLC) is recalling certain 2019 Ram 1500 vehicles equipped with adjustable pedals. The affected vehicles have a brake pedal that may move too far and separate from pedal…
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality…
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
The firm had a report of doctors being unable to pull the obstetric forceps apart.
The firm had a report of doctors being unable to pull the obstetric forceps apart.
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
The firm had a report of doctors being unable to pull the obstetric forceps apart.
There is potential for a piece of the distal tip on the Percuvance shaft to become deformed and possibly break off during use. If a piece did break off it could compromise the functionality…
Stryker s Sustainability Solutions division (SSS) has received an increase in reports indicating that an EEPROM chip error code may occur when Reprocessed 2515 NAV eco Variable…
4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six…
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
The firm had a report of doctors being unable to pull the obstetric forceps apart.
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
There is an anomaly with the Eclipse(TM) Treatment Planning System [TPS] Proton Convolution Superposition [PCS] dose calculation algorithm. The PCS algo- rithm calculates the water…
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
PRISMAFLO II and PRISMAFLO II S Heating Profile only and not the Control Unit, damage may result in a hotspot on the Heating Profile, may cause low level skin burn
Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
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