Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Sterility & contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections.
6,317 FDA drug recalls with this cause, newest first.
This is the single biggest cause in the register by a wide margin. It covers products that had to be sterile - injectables, eye drops, certain ointments - but could not be verified sterile, or were found contaminated during testing. Most of these recalls come from compounding pharmacies and outsourcing facilities after an FDA inspection finds gaps in how sterile products were made. Sterility failures are treated seriously because the products involved have the least room for error, going straight into the bloodstream or the eye.
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
medroxyPROGESTERone Acetate Injectable Suspension
Lack of assurance of sterility
Class II · Moderate risk
Sermorelin Acetate 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PT-141 (Bremelanotide Acetate)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Melanotan II 1 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
LL-37 2 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin Acetate/Sermorelin Acetate
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
BPC-157 2 mg/mL
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
ARA-290 (Cibinetide Acetate)
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Testosterone Cypionate *gs*
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE *GS* Oil 200 MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/PROPIONATE *SES* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ DHEA *GS* 200/10MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
Testosterone Cypionate/ Anastrozole *gs* Oil
Lack of sterility assurance.
Class II · Moderate risk
TESTOSTERONE CYPIONATE/ANASTROZOLE *GS* OIL 200MG/1MG/ML Injectable
Lack of sterility assurance.
Class II · Moderate risk
(ca) Gonadorelin
Lack of sterility assurance.
Class II · Moderate risk
Gonadorelin
Lack of sterility assurance.
Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PAPAVERINE HYDROCHLORIDE Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
TETRACAINE 1% Tetracaine HCI Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Glutathione 200mg/ml
Lack of Assurance of Sterility
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