Class II · Moderate risk Terminated
Methylcobalamin lyophilized
Reason Lack of sterility assurance.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Methylcobalamin lyophilized 50
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Trim Complete
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vitamin D3 50
Reason Lack of sterility assurance.
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 II · Moderate risk Terminated
Oxybutynin Chloride Tablets
Reason Labeling: Wrong bar code
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.
Class II · Moderate risk Terminated
Medline Remedy Essential Barrier Skin Protectant Ointment
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk Terminated
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample