Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Other Drugs
💊 Drugs • 3,200 recalls
Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam Pharma Lic, Bronx, Newyork 10469, NDC 72570 122 35, UPC 3 72570 12235 3.
Global Pharma Healthcare Private Limited
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
CGMP DEVIATIONS
CGMP DEVIATIONS
CGMP Deviations: Raw material recalled by repackager, due to discoloration.
Non-Sterility
CGMP DEVIATIONS
CGMP DEVIATIONS
CGMP Deviations
CGMP DEVIATIONS
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP DEVIATIONS
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Humatrix Microclysmic Gel, 8 oz per bottle, Care-Tech Laboratories, Inc., Saint Louis, Missouri 63139.
Consolidated Chemical
CGMP Deviations: initiated due to violations of CGMP manufacturing practices
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.