Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
Northwind Pharmaceuticals
CGMP Deviations
Prescription and over-the-counter medications
Northwind Pharmaceuticals
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Northwind Pharmaceuticals
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Sun Pharmaceutical Industries
Presence of Particulate Matter: A piece of glass was found in a prefilled syringe.
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Northwind Pharmaceuticals
CGMP Deviations
Wellness BioSciences
Marketed Without an Approved NDA/ANDA
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Northwind Pharmaceuticals
CGMP Deviations
Northwind Pharmaceuticals
CGMP Deviations
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
SCA Pharmaceuticals
Subpotent Drug: Out of specification results for low potency was obtained.
Pharmacy Plus, Inc.
Lack of assurance of sterility.
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Out of specification (OOS) for Spectroscopic Identification test by IR.
Labeling; Incorrect NDC number on outer carton of product.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.