Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1701

The newest recall records with useful source details are listed here.

DrugFeb 8, 2017

VistaPharm Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 recall — FDA D-0457-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

Finasteride Tablets, USP 5 mg, 90-count bottles recall — FDA D-0453-2017

Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.

Class IIIFDA: TerminatedHetero Drugs Ltd. - Unit 1

DrugFeb 8, 2017

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 recall — FDA D-0465-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL) recall — FDA D-0466-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

Ecolab Endure 400 Scrub-Stat (chlorhexidine gluconate) Foam Forming Solution, 4% recall — FDA D-0454-2017

Subpotent Drug

Class IIIFDA: TerminatedEcolab, Inc.

DrugFeb 8, 2017

VistaPharm Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose cups recall — FDA D-0464-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case recall — FDA D-0460-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles recall — FDA D-0467-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL recall — FDA D-0458-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 mL recall — FDA D-0461-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case recall — FDA D-0462-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case recall — FDA D-0463-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

DrugFeb 8, 2017

VistaPharm Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per recall — FDA D-0459-2017

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Class IIFDA: TerminatedVistaPharm, Inc.

Medical DeviceFeb 1, 2017

PerkinElmer Health Sciences AutoDELFIA Plate Processor , Fluorometer, for clinical use recall — FDA Z-1100-2017

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Class IIIFDA: TerminatedPerkinElmer Health Sciences, Inc.

Medical DeviceFeb 1, 2017

Philips Electronics Allura Xper FD20 722012 is intended for: Cardiovascular and vascular recall — FDA Z-0922-2017

Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 1, 2017

Atrium Medical Oasis Blood Recovery Drains as follows: 3650-100 Oasis Blood Recovery drain recall — FDA Z-1086-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

Pentax of Rigid Laryngostroboscopes The Rigid Laryngostroboscopes, Models 9106 and 9108 are recall — FDA Z-1075-2017

Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108.

Class IIFDA: TerminatedPentax of America Inc.

Medical DeviceFeb 1, 2017

Mesa Laboratories ProSpore 4 mL Ampoule Biological indicator for steam sterilization recall — FDA Z-1104-2017

Product resistance has fallen outside of label claim within expiry.

Class IIFDA: TerminatedMesa Laboratories Inc.

Medical DeviceFeb 1, 2017

PerkinElmer Health Sciences DELFIA PC with V3.0 Software, Fluorometer, for clinical use recall — FDA Z-1102-2017

AutoDELFIA System with Version 3.0 Software: Potential plate loading failures

Class IIIFDA: TerminatedPerkinElmer Health Sciences, Inc.

Medical DeviceFeb 1, 2017

Sekisui Diagnostics Ammonia L3K Assay recall — FDA Z-1078-2017

Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

Class IIFDA: TerminatedSekisui Diagnostics P.E.I. Inc.

Medical DeviceFeb 1, 2017

Atrium Medical 3620-100: Oasis dual chamber drain with in-line connectors (2 Patient Tubes) recall — FDA Z-1085-2017

Outer Packaging is not sterile

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceFeb 1, 2017

The Binding Site Group Human lgG Subclass Liquid Reagent Kits for use on the Siemens BN"IJ recall — FDA Z-1072-2017

Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.

Class IIFDA: TerminatedThe Binding Site Group, Ltd.

Medical DeviceFeb 1, 2017

Philips Electronics Velara Generator with an old Firmware version used with Philips Allura recall — FDA Z-1061-2017

System may lock up.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceFeb 1, 2017

Baxter Healthcare Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system recall — FDA Z-1094-2017

Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix Dialysis Machine Preventive Maintenance Kits due to incorrect silicone straight connectors…

Class IIFDA: TerminatedBaxter Healthcare Corporation

Browse by month

Recent recall archives

Browse recent months with enough recall history for useful comparison.

Full archive →