Class III · Low risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Epinephrine/Lidocaine HCl
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
NDC 64380-721-06 Tacrolimus Capsules
Reason Failed Moisture Limits
Class III · Low risk Terminated
Benzhydrocodone and Acetaminophen Tablets
Reason Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class III · Low risk Terminated
Morphine Sulfate 3 mg/3 mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class III · Low risk Terminated
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Reason Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Class III · Low risk Terminated
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Reason Labelling: Missing label.
Class III · Low risk Terminated
Fentanyl
Reason Subpotency: Out-of-specification stability test result for low potency was obtained.
Class III · Low risk Terminated
Scandonest 3% Plain
Reason Labeling: Label mix-up
Class III · Low risk Terminated
DOXOrubicin Hydrochloride Injection
Reason Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class III · Low risk Terminated
Levocetirizine Dihydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Class III · Low risk Terminated
Testosterone Gel 1%
Reason Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Class III · Low risk Terminated
Clobetasol Propionate Ointment USP 0.05%
Reason Superpotent and Subpotent; low and high assay results
Class III · Low risk Terminated
Triamcinolone Acetonide Lotion USP
Reason Subpotent Drug: One lot of Triamcinolone Acetonide Lotion, 0.025% 60 mL.does not meet assay results.
Class III · Low risk Terminated
Olanzapine Orally Disintegrating Tablets
Reason Subpotent
Class III · Low risk Terminated
Felodipine Extended Release Tablets
Reason Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
Class III · Low risk Terminated
Fluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100…
Reason Labeling Not Elsewhere Classified: Ibuprofen Oral Suspension is missing dosing cups.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Dextroamphetamine Saccharate
Reason Labeling: Incorrect expiration date. Product dated with 24-month expiration date instead of 18-months.
Class III · Low risk Terminated
Desflurane
Reason DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.
Class III · Low risk Terminated
Candesartan Cilexetil and Hydrochlorothiazide Tablets
Reason Out-of-specification organic impurity results obtained during routine stability testing.