Class II · Moderate risk
Testosterone Cypionate/Enanthate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
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
Testosterone Cypionate/Enanthate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Methyl-Cobalamin injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Glutathione injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Dexpanthenol injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Calcium Gluconate injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
CoEnzyme-Q10 injectable
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
Ipamorelin 9 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Methylcobalamin 10 mg vial Lyophilized 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Ipamorelin 3 mg Lyophilized 1 vial 1109 East Hallandale Beach Blvd. Hallandale Beach
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 6000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 4000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 2500 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 20000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 11000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Human Chorionic Gonadotropin 5000 IU Vial Lyophilized 1109 East…
Lack of assurance of sterility.
Class II · Moderate risk
Papav 300/Phent 5mg/10mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
P/P/P 0.02/40/2mg/mL
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRO/PA/PH/AT 18mcg/1.8mg/
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PRASH 12.2mcg/1.22m/19.29
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
P/P/P (Prostaglandin/Papaverine/Phentolamine)
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Acetylcysteine 10% Oph Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Medroxprogesterone 1% Ophthalmic Solution
Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.