Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac
Lack of sterility assurance.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,543 recalls, newest first.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Acetylcysteine Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Domperidone 10 mg capsules
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 100 mg SR capsules
Lack of Processing Controls.
Class II · Moderate risk
Promethazine Gel 50 mg/mL
Lack of Processing Controls.
Class II · Moderate risk
Testosterone 0.1% cream
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 10% cream
Lack of Processing Controls.
Class II · Moderate risk
Omeprazole 4 mg/mL Suspension
Lack of Processing Controls.
Class II · Moderate risk
Nevirapine Extended Release Tablets
Failed Dissolution Specifications.
Class II · Moderate risk
Oxybutynin Chloride Tablets
Labeling: Wrong bar code
Class II · Moderate risk
Monsel's (Ferric Subsulfate)
Superpotent Drug: contains higher levels of Iron than labeled.
Class II · Moderate risk
Clopidogrel Tablets
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
Medline Remedy Essential Barrier Skin Protectant Ointment
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Soothe & Cool Protect Moisture Guard Skin Protectant
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Levoxyl (levothyroxine sodium tablets, USP)
Superpotent Drug.
Class II · Moderate risk
Fentanyl Citrate 2 mcg per mL
Sub-potent
Class II · Moderate risk
Fentanyl Citrate 2 mcg per mL
Sub-potent
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Class II · Moderate risk
Valsartan and Hydrochlorothiazide Tablets
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.