FDA (Drugs) recall action 74606
The FDA (Drugs) publishes a recall like this one as 5 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 5 pages.
Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
The agency’s own wording, quoted from the enforcement report.
The Apothecary is recalling Calcium Gluconate IV bags because the pharmacy could not verify that the products remained sterile for their labeled duration.
The Apothecary is recalling unexpired lots of sterile injection medications due to unsubstantiated validation of beyond-use dating, which raises concerns about sterility.
The Apothecary is recalling Calcium Gluconate syringes due to unsubstantiated validation of beyond use dating and lack of sterility assurance.
The Apothecary is recalling unexpired lots of Papaverine, Phentolamine, Calcium Gluconate, and Prostaglandin medications due to unsubstantiated validation of beyond use dating and lack of sterility assurance.
The Apothecary is recalling specific lots of Prostaglandin and other medications due to a lack of assurance of sterility and unsubstantiated validation of beyond-use dating.