💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
All Recalls
95,038 total recalls in our database
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications:
💊 Drugs Class I - Dangerous
cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.
💊 Drugs Class I - Dangerous
cGMP Deviations: Potential glass contamination
Fexofenadine HCl Tablets, 180 mg, Pkg Size 90, Mfg: Aurohealth LLC, Repackaged by Preferred Pharmaceuticals, Inc., Anaheim, CA, NDC #: 68788-6848-09
Preferred Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
cGMP Deviations: Potential glass contamination
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
💊 Drugs Class I - Dangerous
cGMP Deviations: Potential glass contamination
Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0204-02
Shire Human Genetic Therapies
💊 Drugs Class I - Dangerous
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartridges, Rx only, For subcutaneous use only, Manufactured for: Shire-NPS Pharmaceuticals, Inc., Lexington, MA NDC 68875-0203-02
Shire Human Genetic Therapies
💊 Drugs Class I - Dangerous
Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
💊 Drugs Class I - Dangerous
Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
💊 Drugs Class I - Dangerous
Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Accu-Chek Connect Diabetes Management App
Roche Diabetes Care
🏥 Medical Devices Class I - Dangerous
Users with Android OS 8.0 and above may be unable to transfer values obtained on their meter to the App.
QuickGraft¿ Model # 430PST
Musculoskeletal Transplant Foundation
🏥 Medical Devices Class I - Dangerous
Measurement listed on the label is not taken under tension, and this would cause possible extension of surgical time needed to complete the procedure.
Products may contain the incorrect banner card within the kit
Randox Urinalysis Control Level 2 (IVD) Ref: UC5034 - Product Usage: Product is intended for in vitro diagnostic use in the quality control of urine test strips.
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Analyte range for Leukocytes for use with the Siemens Multistix method is incorrect. The range was corrected to NEGATIVE to 3+.
It is possible that the forced electron density settings will be changed for some structures unintentionally and this can result in incorrect dose calculation.
🏥 Medical Devices Class I - Dangerous
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
Customers who utilize PharmGuard¿ Server Software (PGS) with Medfusion¿ 4000 pumps manufactured prior to November 10, 2017, may experience wireless network connectivity issues on certain pumps due to a potential Radio Module issue on some Medfusion¿ 4000 pumps.
Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in the aCCP Test Definition (TDef). The issue occurs on an Atellica IM Analyzer and is isolated to TDef Version 1.0. FOR OUS: Atellica IM anti-CCP IgG (aCCP) and Pregnancy-Associated Plasma Protein-A (PAPP-A) Test Definition (TDef) Mitigation Failure