Reason: Labeling: Not Elsewhere Classified: Label indicates that the product contains Vitamin B12 (12 micrograms) on the Supplement Facts panel, however, the formulation of this product does not contain Vitamin B12.
Distributed: NationwideReason: Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Distributed: NationwideReason: Presence of Particulate Matter: identification of particulates in a retention sample that have been identified as a mixture of the amino acid leucine and inorganic material (containing iron, silicone and chlorine).
Distributed: NationwideReason: Failed Dissolution Specifications: Dissolution failures found during testing of control samples at the four hour time point.
Distributed: NationwideReason: Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Distributed: Nationwide and Puerto Rico.Reason: Failed Impurities/Degradation Specifications; Out of specification for lactol and total impurities.
Distributed: U.S. NationwideReason: Failed Tablet/Capsule Specifications: Teva is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg due to the potential for superpotent tablets.
Distributed: NationwideReason: Failed pH Specification: A pH result of 2.9 was obtained at the 9 month stability test interval at 25C/60%RH. The registered specification for pH is 3.0 - 7.0
Distributed: NationwideReason: Subpotent Drug: Low out of specification results for both pH and assay obtained during routine stability testing after 36 months.
Distributed: Nationwide and Puerto RicoReason: Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and chlorzoxazone.
Distributed: US nationwide and Korea