DrugAug 22, 2018
RemedyRepack Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays recall — FDA D-1102-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: TerminatedRemedyRepack Inc.
Latest records
Latest recalls — page 1378
The newest recall records with useful source details are listed here.
DrugAug 22, 2018
Ranier's Compounding Laboratory Papav 300/Phent 5mg/10mL (Papaverine/Phentolamine) recall — FDA D-1094-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
DrugAug 22, 2018
Ranier's Compounding Laboratory Acetylcysteine 10% Oph Solution, 10 mL droptainer recall — FDA D-1089-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
DrugAug 22, 2018
Huijing (Shanghai) Bio-tech Co Acne Treatment Pads (2% salicylic acid) recall — FDA D-1076-2018
Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.
Class IIIFDA: TerminatedHuijing (Shanghai) Bio-tech Co., Ltd.
DrugAug 22, 2018
Ranier's Compounding Laboratory PRASH 12.2mcg/1.22m/19.29 recall — FDA D-1091-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
DrugAug 22, 2018
RemedyRepack Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays recall — FDA D-1101-2018
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Class IIFDA: TerminatedRemedyRepack Inc.
DrugAug 22, 2018
Ranier's Compounding Laboratory Avastin 1.25 mg/0.05 mL prefilled syringe recall — FDA D-1082-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
DrugAug 22, 2018
Ranier's Compounding Laboratory P/P/P 0.02/40/2mg/mL recall — FDA D-1093-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
DrugAug 22, 2018
Ranier's Compounding Laboratory P/P/P recall — FDA D-1090-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
DrugAug 22, 2018
Ranier's Compounding Laboratory Triple P recall — FDA D-1083-2018
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class IIFDA: TerminatedRanier's Compounding Laboratory
VehicleAug 22, 2018
Volvo XC40 pedals and linkages recall — NHTSA campaign 18V554000
Volvo Car USA LLC (Volvo) is recalling certain 2019 Volvo XC40 vehicles. The brake pedals may not have been correctly riveted, allowing the pedal to move out of position, possibly reducing…
pedals and linkagesVolvo Car USA LLC
Medical DeviceAug 15, 2018
Howmedica Osteonics rHead Recon Stem Implant Plasma Coated, Size 1 recall — FDA Z-2685-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
Howmedica Osteonics rHead, Radial Implant 6 mm Collar, Size 1 recall — FDA Z-2726-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
Beaver Visitec Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in recall — FDA Z-2740-2018
Mislabel of product 373726 Lot 6001700 with 374891 Lot 6001701 on individual packages within the correctly labeled shelf carton.
Class IIFDA: TerminatedBeaver Visitec
Medical DeviceAug 15, 2018
ICU Medical 88" (224 cm) Y-Type Blood Set w/200 Micron Filter, Hand Pump, MicroClave recall — FDA Z-2618-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceAug 15, 2018
ICU Medical 159" (404 cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, Remv 4-Way recall — FDA Z-2649-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceAug 15, 2018
ICU Medical 119" Blood Set w/200 Micron Filter, Clave, Rotating Luer, Sterile The blood recall — FDA Z-2606-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceAug 15, 2018
Howmedica Osteonics rHead Recon Stem Implant 6mm Collar, Size 4 recall — FDA Z-2692-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
Howmedica Osteonics Radio Capitellum Small, Right recall — FDA Z-2696-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
Howmedica Osteonics rHead Standard Extended Stem, 6mm Collar, Size 1 recall — FDA Z-2703-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
Howmedica Osteonics rHead, Radial Implant 6 mm Collar, Size 3 recall — FDA Z-2730-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
Howmedica Osteonics Lat Assembly, Rad Stem Implant,Collar 6mm,Size 3 recall — FDA Z-2669-2018
Revision rate identified as higher than other proximal radial head replacement devices based on literature review. Product may not perform at expected level post-surgery.
Class IIFDA: TerminatedHowmedica Osteonics Corp.
Medical DeviceAug 15, 2018
ICU Medical 100" (254 cm) 20 Drop Y-Type Blood Set w/200 Micron Filter, Hand Pump, 2 Clave recall — FDA Z-2632-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Class IIFDA: TerminatedICU Medical, Inc.
Medical DeviceAug 15, 2018
ICU Medical 120" (305cm) Y-Type Blood Set w/170 Micron Filter, Hand Pump, 3 Clave, Rotating recall — FDA Z-2627-2018
Some devices were labeled as Does not contain DEHP even though the product may contain small amounts of DEHP.
Class IIFDA: TerminatedICU Medical, Inc.
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Recent recall archives
Browse recent months with enough recall history for useful comparison.
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