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Lack of sterility assurance.
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Failed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Lack of Assurance of Sterility: Complaints of leaks due to an incomplete seal at the bag seam.
Failed Impurities/Degradation Specifications: High out of specification results for the known impurity p-Aminophenol.
Product contains anabolic steroid.
Lack of Assurance of Sterility: The product has the potential for solution to leak at the administrative port.
Labeling: Incorrect or Missing Lot and/or Exp. Date - The subject lot is missing the lot number and expiration date stamp on the primary box..
Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.
Marketed without an Approved NDA/ANDA; found to contain Lorcaserin, a controlled substance used for weight loss