Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
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
Calm Me Vitamin Cocktail
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
B1/B2/B5/B12/Lidocaine/Isoleucine/Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
B1/B2/B3/B5/B12/Lidocaine/Isoleucine/Methionine/Choline/Inositol
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil/Procaine
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Alprostadil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow…
Lack of Assurance of Sterility: The firm received a complaint of a sterility failure using a non-validated sterility test on a medication cassette.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint for customer of presence of particulate matter, leaky containers, and missing port protectors.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIH-Hydroxyprogesterone Caproate 250
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Phentolamine 5 mg/mL in Normal Saline
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Prostaglandin E1 500 mcg/mL Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SO-Acetylcysteine 10% Sterile Ophthalmic Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/20 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24 mg/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/2/20 Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 30/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 24/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 20/1 mg/10 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/10 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 6/0.33/3.33 Injection Solution
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 18/1/20 Injection
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
SIU-Tri-Mix 17/0.6/5.7 Injectable
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
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