Prescription and over-the-counter medications
Brookfield Prescription Center Inc.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Forest Pharmaceuticals
Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Brookfield Prescription Center Inc.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Caraco Pharmaceutical Laboratories
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Pfizer Us Pharmaceutical Group
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Subpotent Drug.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Failed Stability Specification; out of specification result for particle size distribution during stability testing
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.