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Sub-Potent Drug: Subpotent assay results during stability testing.
Failed Impurity/Degradation Specifications
Downstream recall of a dietary supplement ingredient that was manufactured out of specification.
Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Failed Impurities/Degradation Specifications.
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Presence of a foreign substance: black hair found embedded in tablet.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Product is mislabeled.
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Cross Contamination
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Superpotent; sodium benzoate preservative
Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.
Labeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.