Reason: Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Distributed: NationwideReason: Failed Dissolution Specifications: Drug failed stage III dissolution testing.
Distributed: Nationwide including Puerto Rico.Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Distributed: Nationwide, Puerto Rico, Canada, and Hong Kong.Reason: Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Distributed: Nationwide, Puerto Rico, Canada, and Hong Kong.Reason: 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.
Distributed: NationwideReason: Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Distributed: Nationwide and Puerto RicoReason: Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Distributed: OHReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: NationwideReason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Distributed: Nationwide