Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Valeant Pharmaceuticals North America
25 recalls • • Categories: Prescription Drugs, Over-the-Counter, Other Drugs, Other Medical Devices
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
Failed Dissolution Specifications: high out of specification results for dissolution when measuring the amount of drug released at certain time points.
💊 Drugs Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
💊 Drugs Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
💊 Drugs Class I - Dangerous
CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert - Obagi-C Rx System C-Therapy Night Cream is being recalled due to incomplete packaging/labeling. The bottle is missing the product insert and outer carton which contain the complete instruction for use and safety information.
💊 Drugs Class I - Dangerous
Discoloration.
Discoloration.
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Failed Impurities/Degradation Specifications
Failed Impurities/Degradation Specifications
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
🏥 Medical Devices Class I - Dangerous
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
💊 Drugs Class I - Dangerous
Failed Dissolution Specifications: Failed 24 month dissolution testing.
Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Labeling: Incorrect or Missing Package Insert
Labeling: Incorrect or Missing Package Insert
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert
💊 Drugs Class I - Dangerous
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package outset
Labeling: Incorrect or Missing Package Insert: Product is packaged with the incorrect version of the package insert.