FDA (Drugs) recall action 71618
The FDA (Drugs) publishes a recall like this one as 28 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 28 pages.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced..
The agency’s own wording, quoted from the enforcement report.
The Apothecary Shoppe is recalling SIU-Phent .8/PGE1 20 mcg/mL Injection vials because proper environmental monitoring documentation was missing during production.
The Apothecary Shoppe LLC is recalling S-Methylcobalamin 5000 mcg/mL Injection in 750 mL containers due to a lack of assurance of sterility.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/10 Injection vials in Oklahoma due to a lack of documentation for environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/1/20 Injectable in Oklahoma due to a lack of documentation ensuring proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 18/1/10 Injection because proper environmental monitoring documentation was missing during production.
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 500 mcg/mL Injection vials in Oklahoma due to lack of documentation for environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 30/2/20 Injection in Oklahoma due to a lack of documentation proving proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 20/1 mg/10 mcg/mL vials because proper environmental monitoring documentation was missing during production.
The Apothecary Shoppe LLC is recalling SIU-Phent .4 mg/PGE1 20 mcg/mL Injection due to a lack of documentation for environmental monitoring during production.
The Apothecary Shoppe is recalling specific vials of Papaverine and Phentolamine Injection because documentation for environmental monitoring during production was missing.
The Apothecary Shoppe is recalling Hydroxyprogesterone Caproate 250 vials due to lack of documentation for environmental monitoring during production.
The Apothecary Shoppe is recalling specific lots of Testosterone Cypionate Injection due to a lack of documentation confirming proper environmental monitoring during production.
The Apothecary Shoppe is recalling SIU-Tri-Mix 18/1/20 Injection because documentation for environmental monitoring during production was missing.
The Apothecary Shoppe LLC is recalling SIU-Prostaglandin E1 20 mcg/mL Injection due to a lack of documentation ensuring proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SIH-Testosterone Cypionate Injection because proper environmental monitoring documentation is missing, raising concerns about sterility.
The Apothecary Shoppe is recalling specific lots of SIU-Papav/Phentol 30/1 mg/mL Injection due to a lack of documentation for environmental monitoring during production.
The Apothecary Shoppe is recalling S-methylcobalamin 25 mg/mL injection vials because documentation for environmental monitoring during production was missing.
The Apothecary Shoppe is recalling HCG 1000 U/mL Injection vials because proper environmental monitoring documentation was missing during production.
The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentolamine Injection due to a lack of documentation confirming proper environmental monitoring during production.
The Apothecary Shoppe is recalling SIU-Tri-Mix Injection Solution because proper environmental monitoring documentation was missing during production.
The Apothecary Shoppe is recalling SIU-Tri-Mix 24/1/20 Injection vials because documentation for environmental monitoring during production was missing, raising concerns about sterility.
The Apothecary Shoppe LLC is recalling SIU-Tri-Mix 17/0.6/5.7 Injectable in Oklahoma due to lack of assurance of sterility from missing environmental monitoring documentation.
The Apothecary Shoppe is recalling S-Methylcobalamin 1000 mcg/mL Injection because documentation for environmental monitoring during production was missing.
The Apothecary Shoppe LLC is recalling specific vials of Papaverine and Phentermine Injection due to a lack of documentation proving proper environmental monitoring during production.
The Apothecary Shoppe LLC is recalling SO-Acetylcysteine 10% Sterile Ophthalmic Solution due to lack of documentation for environmental monitoring during production.