💊 Drugs Class I - Dangerous
Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
All Recalls
95,102 total recalls in our database
Enalapril Maleate Tablets, USP; 20 mg; 90 tablets, NDC 60429-186-90; manufactured by Taro Pharmaceutical Industries, Ltd.; packaged by GSMS, Incorporated, CA.
Golden State Medical Supply
💊 Drugs Class I - Dangerous
CGMP Deviations
Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Wedgewood Village Pharmacy
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
💊 Drugs Class I - Dangerous
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-385-02), Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Baddi Himachal Pradesh 173205, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah NJ 07430.
Glenmark Pharmaceuticals Inc., USA
💊 Drugs Class I - Dangerous
Defective Container
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Wedgewood Village Pharmacy
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
Wedgewood Village Pharmacy
💊 Drugs Class I - Dangerous
Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
🏥 Medical Devices Class I - Dangerous
Potential to display inaccurate measurements on images in Centricity Universal Viewer Zero Footprint Client (ZFP)
🏥 Medical Devices Class I - Dangerous
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
🏥 Medical Devices Class I - Dangerous
The outer package is mislabeled and the package contains a different IOL strength.
Omnera 400A Digital Radiographic System
Arcoma AB
🏥 Medical Devices Class I - Dangerous
There is the potential for the X-Ray system to short circuit due to an ingress of liquid in the display handles which may result in uncontrolled movement of the Overhead Tube Crane (OTC).
Clean Catch Urine Kit NS 178489, AHMU58A
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Affected products were assembled off-site by individuals who may not have been properly trained.
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444896/RF521
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
Nasopharyngeal sample collection tray for COVID-19 testing, labeled as COVID TEST KIT NONSTERILE 184312, AHCV18A
American Contract Systems
🏥 Medical Devices Class I - Dangerous
Affected products were assembled off-site by individuals who may not have been properly trained.
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction. Siemens Material Number (SMN)/REF (Catalog Number): 10444905/RF421C
Siemens Healthcare Diagnostics
🏥 Medical Devices Class I - Dangerous
Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction
🏥 Medical Devices Class I - Dangerous
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
MassCheck Amino Acid, Acylcarnitines Dried Blood Spot Control Level I
Chromsystems Instruments & Chemicals GmbH
🏥 Medical Devices Class I - Dangerous
Too low concentration of glycine was detected in the dried blood controls of the batch 2821 of the products.