Testosterone Regular Release 200 MG, 1 PELLET (STERILE) FOR SUBCUTANEOUS INSERTION, RX ONLY, FarmaKeio Outsourcing, 920 S Kimball…
Reason CGMP Deviations: Potential presence of metal particulate matter
411 FDA recalls mention Testosterone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Testosterone.
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason CGMP Deviations: Potential presence of metal particulate matter
Reason Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Reason Marketed Without an Approved NDA/ANDA
Reason Lack of Assurance of Sterility
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason Presence of Particulate Matter: Glass particles were found in pellet vials.
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Reason Presence of foreign substance: Presence of Benzene.
Reason Presence of foreign substance: Presence of Benzene.
Reason Superpotent Drug
Reason OOS for viscosity
Reason Lack of Assurance of Sterility
Reason cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Reason Superpotent Drug: Out of specification assay result was obtained during stability testing.
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