Class II · Moderate risk Terminated
Vitamin D3 50
Reason Lack of sterility assurance.
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Class II · Moderate risk Terminated
Multi Trace
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vitamin B Complex
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prednisolone and Bromfenac Ophthalmic Solution
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prednisolone and Gatifloxacin and Bromfenac
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Acetylcysteine Ophthalmic Solution
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Domperidone 10 mg capsules
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Progesterone 100 mg SR capsules
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Promethazine Gel 50 mg/mL
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Testosterone 0.1% cream
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Progesterone 10% cream
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Omeprazole 4 mg/mL Suspension
Reason Lack of Processing Controls.
Class II · Moderate risk Terminated
Nevirapine Extended Release Tablets
Reason Failed Dissolution Specifications.
Class I · High risk Terminated
Lubrisine eye drops
Reason Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class I · High risk Terminated
Dyural-80 Injection Kit
Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Class I · High risk Terminated
Dyural-40 Injection Kit
Reason Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Class II · Moderate risk Terminated
Oxybutynin Chloride Tablets
Reason Labeling: Wrong bar code
Class III · Low risk Terminated
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk Terminated
Advanced Protection Sunscreen spf 30
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class II · Moderate risk Terminated
Monsel's
Reason Superpotent Drug: contains higher levels of Iron than labeled.
Class II · Moderate risk Terminated
Clopidogrel Tablets
Reason Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.