Prescription and over-the-counter medications
DIBAR NUTRICIONAL S DE RL DE CV
Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol.
DIBAR NUTRICIONAL S DE RL DE CV
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
DIBAR NUTRICIONAL S DE RL DE CV
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
NSNY Distributor
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper.
Presence of Foreign Substance: Foreign particles observed during routine stability testing.
Bausch Health Companies
Failed Impurities/Degradation Specifications
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil.
Bausch Health Companies
Failed Impurities/Degradation Specifications
Prisma Health Outsourcing Facility
Labeling: Incorrect Exp. Date: Incorrect BUD.
Failed Impurities Specification: Out of specification when measuring the impurity degradant D level.
Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine
Dr. Reddy's Laboratories
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Subpotent
Fresenius Medical Care Holdings
Temperature Abuse: Product exposed to temperature outside specified limits.
Fresenius Medical Care Holdings
Temperature Abuse: Product exposed to temperature outside specified limits.