💊 Drugs • 11,927 recalls
Ummzy
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Partner Therapeutics
FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.
CGMP Deviations
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Teva Pharmaceuticals USA
Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. The vial was returned to Teva for further analysis where two other particulates were found and identified as one (1) grey silicone particle and one (1) translucent, colorless cotton fiber.
Low out of specification results for epinephrine assay.
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
NSNY Distributor
Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil
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.
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.