Class II · Moderate risk
Acetylcysteine Ophthalmic Solution
Lack of sterility assurance.
FDA Drug Recalls
11,818 recalls · Class II, newest first
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
Estradiol Tablets
Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
Infants' Ibuprofen
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
infants* IBUPROFEN
Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk
Germ Bloc Health Hand Sanitizer Foam
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class II · Moderate risk
Human Chorionic Gonadotropin 3000 IU
Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk
FastStat Topical Hemostat Introductory Kit
cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk
BeeGentle Honey Flavored Topical Anesthetic
cGMP violations noted during the firm's most recent inspection.