Class II · Moderate risk Terminated
Promethazine Gel 50 mg/mL
Reason Lack of Processing Controls.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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
Class II · Moderate risk Terminated
Soothe & Cool Protect Moisture Guard Skin Protectant
Reason GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk Terminated
Levoxyl
Reason Superpotent Drug.
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Terminated
Fentanyl Citrate 2 mcg per mL
Reason Sub-potent
Class II · Moderate risk Terminated
Estradiol Tablets
Reason 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 Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
Infants' Ibuprofen
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
infants* IBUPROFEN
Reason Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
Class II · Moderate risk Terminated
Germ Bloc Health Hand Sanitizer Foam
Reason Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class II · Moderate risk Terminated
Human Chorionic Gonadotropin 3000 IU
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
FastStat Topical Hemostat Introductory Kit
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
BeeGentle Honey Flavored Topical Anesthetic
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
SHEER DesenZ Desensitizing Treatment
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
fas.TRACT Coagulative Hemostatic Gel
Reason cGMP violations noted during the firm's most recent inspection.
Class II · Moderate risk Terminated
Quetiapine Tablets USP 400 mg
Reason Presence of Foreign Substance; metal shard found in tablet