1,525 recalls · Class III, newest first
Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a failure to meet the % RSD requirement in the test for Droplet Size during the 6 month long term stability test station
Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitted from the product carton, primary label is correct.
Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Subpotent Drug: Out of specification for assay (stability testing)
Superpotent drug: failed assay throughout the stick after 6 months stability.
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage.
Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration.
Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station.
Presence of foreign substance: metallic razor blade was found in one bottle.
Failed Content Uniformity Specifications
Subpotent Drug
Subpotent Drug
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle.