Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility: Recalling firm reported a complaint for mold on the interior surface of the overpouch.
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
Bromfenac Ophthalmic Solution 0.09%
Lack of Assurance of Sterility: Failed preservative effectiveness testing
Class II · Moderate risk
Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution
Lack of Assurance of Sterility; potential exposure to non-sterile lubricant during the filling process
Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class I · High risk
Prolotherapy with Phenol
Non-Sterility: Hartley Medical Center Pharmacy, Inc. is recalling Prolotherapy with Phenol due to non-sterility concerns.
Class II · Moderate risk
Bromfenac Ophthalmic Solution
Lack of Assurance of Sterility: Failed preservative effectiveness testing.
Class II · Moderate risk
Vitamin D3 Oil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Vitamin D3 Oil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Vitamin B-Complex
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Trimix
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone/Anastrozole
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone/Anastrozole
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Proprionate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Cypionate for Subq Injection
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Cypionate for Subq Injection
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone Cypionate
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Testosterone
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
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