Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
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
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Fentanyl Citrate Inj.
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Class I · High risk
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
BD ChloraPrep Clear
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Class I · High risk
ChlroraPrep One-Step
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
ChloraPrep With Tint
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class I · High risk
BD ChloraPrep Clear 3 mL Applicators
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
Class II · Moderate risk
Sterile Curcumin 50mg/mL
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Curcumin
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Sterile Cannabidiol
Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unapproved Cannabidiol and Curcumin
Class II · Moderate risk
Alprostadil 10mcg/Papaverine 30mg/Phentolamine 1mg/ml lnj Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Testosterone Cypionate In Sesame Oil 200mg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Class II · Moderate risk
MIC-8 (Methionine 15mg /Inositol 50 mg/Choline 100 mg/B-12 6mcg/ml)
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin Soln. 1000 mcg/ml
Lack of Assurance of Sterility
Class II · Moderate risk
Ceftazidime Sterile Ophthalmic Solution for Injection Preservative Free 11.25mg / 0.5ml
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk
Methotrexate
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk
fentaNYL Citrate Injection 50 mcg per mL
Firm is recalling 46 lots of various products because of a lack of sterility assurance.
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