Lack of Assurance of Sterility
Prescription Drugs
💊 Drugs • 11,927 recalls
CGMP Deviations
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count HDPE bottles NDC# 72578-036-01
VIONA PHARMACEUTICALS
CGMP Deviations- Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Failed Dissolution Specifications.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations
Lack of Assurance of Sterility
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Aurobindo Pharma USA
Superpotent and Failed Tablet/Capsule Specifications
cGMP deficiencies
Lack of Assurance of Sterility
Failed Dissolution Specifications
Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.