Class III · Low risk Terminated
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Reason Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
FDA Drug Recalls
14,801 recalls, newest first
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.
Class III · Low risk Terminated
Absorica
Reason Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
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 III · Low risk Terminated
NYSTATIN Oral Suspension
Reason Failed Impurities/Degradation Specifications:Out of specification for impurities.
Class III · Low risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets
Reason Discoloration: This product is being recalled due to a confirmed pharmacist report that tablets from this lot were a pink color instead of cream (peach).
Class I · High risk Terminated
Phenylephrine HCl
Reason Labeling: Label Error on Declared Strength: Label incorrectly lists concentration as "10 mcg per mL" rather than the correct concentration of "100 mcg per mL".
Class III · Low risk Terminated
Aprepitant Capsules
Reason Shortfill: Aprepitant capsules 40 mg is being recalled due to customer reports of missing capsule in the blister pack.
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 III · Low risk Terminated
Norepinephrine 8 mg
Reason Incorrect excipient: Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
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.