💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
All Recalls
95,089 total recalls in our database
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
💊 Drugs Class I - Dangerous
Subpotent Drug
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Finasteride Tablets, USP 5 mg, 90-count bottles, Rx only, Manufactured for : Camber Pharmaceuticals, Inc. Piscataway, NJ 08854 By: Hetero Hetero Labs, Unit V Polepally, Jadcheria, Mahaboob Nagar - 509 301, India Limited NDC 31722-525-90
Hetero Drugs Ltd. - Unit 1
💊 Drugs Class I - Dangerous
Failed Tablet/Capsule Specification: Tablets were found to be twice the thickness in one lot of product.
💊 Drugs Class I - Dangerous
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Flucanozole Tablets, USP, 200 mg, a) 30 count (NDC 55111-146-30) and b) 100 count (NDC 55111-146-01) bottles, Rx Only, Mfd. by: Dr. Reddy's Laboratories, Bachupally 500 090 India
Dr. Reddy's Laboratories
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications; 18 month stability time point
MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05
Fresenius Kabi USA
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications
Cryptococcal Antigen Lateral Flow Assay (CrAg LFA), Reference # CR2003
Immuno-Mycologics
🏥 Medical Devices Class I - Dangerous
The affected products have approximately a 91% specificity while the non-affected lots have approximately a 99% specificity. The recalling firm is aware of three customers who reported false positive results.
🏥 Medical Devices Class I - Dangerous
Product sterility compromised due to breach of sterile barrier
🏥 Medical Devices Class I - Dangerous
labeling for specific lots of the Standard OSS Modular Proximal Tibia incorrectly identifies the components as AVL Modular Proximal Tibia. The mislabeling could have the potential risks: A delay in surgery less than 30 minutes. Patient undergoes a revision with increased risk of infection.
Cannulated Drill bit 2.0mm and 2.6 mm; Used in conjunction with the Flower Bone Screw Set.
Flower Orthopedics
🏥 Medical Devices Class I - Dangerous
The product is being recalled due to incidence and reports of the product breaking during surgery.
🏥 Medical Devices Class I - Dangerous
Negative bias results with the IMMULITE¿ /IMMULITE¿ 1000 Third Generation PSA (prostate-specific antigen) kit was confirmed for two lots (D0119 and D0120). The investigation by Siemens has confirmed that patient samples exhibit an average negative bias of approximately -22% with a range of -16% to -27% for samples recovering from 0.08 to 16.2 ng/mL.
SwishTapered Implant
Implant Direct Sybron Manufacturing
🏥 Medical Devices Class I - Dangerous
The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.
Olympus Scientific Solutions Americas Corporation ( OSSA ) VANTA¿ XRF Analyzer. Model Vanta VCR and Vanta VMR Analytical X-ray systems
Olympus Scientific Solutions Americas
🏥 Medical Devices Class I - Dangerous
It was discovered under rare circumstances the LED warning light circuit could fail. If this happens, while the instrument is emitting X-rays during at test, the LED warning lights will not illuminate. The test runs normally and will execute as before, but the light will not be on.