Class II · Moderate risk
Phenotolamine 0.4mg/Prostaglandin 20mcg/mL packaged in 2.5 mL sterile vials
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
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
Methylcobalamin 5000 mcg/mL Injection
Lack of Assurance of Sterility; medication was sterilized with a recalled filter
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Wash
Lack of assurance of sterility
Class II · Moderate risk
Eye Irrigating Solution
Lack of assurance of sterility
Class I · High risk
Eye Wash
Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples.
Class II · Moderate risk
Phenylephrine HCI Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
Class I · High risk
Honeywell eyesaline Eyewash Sterile Isotonic Solution
Non Sterility; contaminated with Klebsiella pneumoniae
Class II · Moderate risk
Ephedrine Sulfate Injection
Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.
Class II · Moderate risk
Betamethasone Acetate / Betamethasone Sodium Phosphate Injectable Suspension
Lack of processing controls: Isomeric Pharmacy Solution, LLC is recalling Betamethasone Acetate / Betamethasone Sodium Phosphate 7 mg/mL INJ SUSP because of the potential of drug clumps in the vial of the sterile drug product and larger particle sizes.
Class II · Moderate risk
C-Pav/Phentol/Atrop/Pge1
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk
C-Pav/Phentol/Pge1
Lack of Assurance of Sterility; sterility concerns with all injectable drug products that were made with sterilized filtered stock solutions.
Class II · Moderate risk
DMSO 50% with Lidocaine 0.5%
Lack of Assurance of Sterility
Class II · Moderate risk
Hyaluronidase
Lack of Assurance of Sterility
Class II · Moderate risk
C-PAP/PHEN/PROST/Atrop 150/7.5
Lack of Assurance of Sterility
Class II · Moderate risk
Olopatadine 0.8% Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
C-Pap/Phen/Prost/Atrop 150/5/5
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyzine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln + Tetracaine
Lack of Assurance of Sterility
Class II · Moderate risk
Pre-Op Pledget Soln
Lack of Assurance of Sterility
Class II · Moderate risk
Autologous Serum Tears
Lack of Assurance of Sterility
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility
Class II · Moderate risk
Morphine Sulfate 15mg/ml Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Moxifloxacin HCl 1 mg/ml
Lack of Assurance of Sterility
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