Class III · Low risk
Norepinephrine Bitartrate Injection
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Dodex Injectable Cyanocobalamin Injection
Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class III · Low risk
Bevacizumab 2.5 mg/0.1 mL
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class III · Low risk
Montelukast Sodium Oral Granules USP
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class III · Low risk
Dofetilide Capsules
Failed Content Uniformity Specifications
Class III · Low risk
Colchicine Tablets
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
Class III · Low risk
Fentanyl 1
Subpotent Drug
Class III · Low risk
Dibucaine 1% Hemorrhoidal Ointment
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Gabapentin Tablets
Presence of Foreign Tablets/Capsules: Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg 500 count bottles.
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class III · Low risk
Buprenorphine Transdermal System
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Class III · Low risk
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class III · Low risk
Bd-102 Nf
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH- 102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH- 101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Clobetasol propionate Cream USP
Subpotent Drug: Low assay result observed during long-term stability testing.
Class III · Low risk
FentaNYL Citrate 2.5mg/50mL
Short Fill: Underfilled units.
Class III · Low risk
Levofloxacin Tablets
Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
Class III · Low risk
SINUVA (mometasone furoate)
Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.
Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class III · Low risk
Timolol Maleate Ophthalmic Solution
Failed Stability Specifications: Out of specification for weight loss at the 18-month stability timepoint and projected weight loss of 21.1% at shelf life.
Class III · Low risk
Lacosamide Oral Solution
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Class III · Low risk
Allergy Relief D
Failed dissolution specifications
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.