Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
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
17-Hydroxyprogesterone 250 mg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Doxycycline/0.9 % NaCl 100 mg/100 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Tobramycin 14 mg/mL Ophthalmic Solution
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Doxcycline/0.9% NaCl 150 mg/150 mL IV
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Vancomycin 25 mg/mL Opthalmic Solution
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papaverine/Phentolamine/Atropine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Papaverine/Phentolamine/PGE-1 Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Cyanocobalamin 500 mcg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Trypan Blue 0.3%
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Brilliant Blue G BBG
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
Tri-Mix T-50/PGE 2/LIDO 2 0.09/0.32/0.04 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 2/LIDO 2 0.03/0.18/0.09 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50/PGE 1 0.14/0.08 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-50 8.8 mg/0.29 mg/2.9 mcg Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-106/PGE 2 0.1/0.14 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-106
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-105
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-102/PGE 2/LIDO 2 0.06/0.3/0.2 Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Tri-Mix T-102
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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