Class III · Low risk Terminated
Fentanyl Buccal Tablets CII
Reason Labeling: Incorrect or Missing Package Insert
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Gabapentin Tablets
Reason Product mixup: one foreign tablet found in product.
Class III · Low risk Ongoing
Lidocaine Patch 5%
Reason Labeling: Typographical error on the upper left-hand side of the box and individual patch label that has the incorrect dosage form stating, each tablet contains instead of each adhesive patch contains.
Class III · Low risk Terminated
Avicel DG
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-200 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-102 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-101 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL
Reason Subpotent Drug: Out of specification results for low potency was obtained.
Class III · Low risk Terminated
Norepinephrine Bitartrate Injection
Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III · Low risk Terminated
Dodex Injectable Cyanocobalamin Injection
Reason Sub-potent drug: assay test result below specifications at 9-month timepoint.
Class III · Low risk Terminated
Bevacizumab 2.5 mg/0.1 mL
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class III · Low risk Terminated
Montelukast Sodium Oral Granules USP
Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Class III · Low risk Ongoing
Epinephrine Professional EMS
Reason Labeling; Incorrect NDC number on outer carton of product.
Class III · Low risk Terminated
Dofetilide Capsules
Reason Failed Content Uniformity Specifications
Class III · Low risk Ongoing
Mektovi
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Class III · Low risk Terminated
Colchicine Tablets
Reason 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 Terminated
Fentanyl 1
Reason Subpotent Drug
Class III · Low risk Ongoing
Evamist
Reason Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month stability time point.
Class III · Low risk Terminated
Dibucaine 1% Hemorrhoidal Ointment
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Gabapentin Tablets
Reason 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 Terminated
Buprenorphine Transdermal System
Reason 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 Terminated
Buprenorphine Transdermal System
Reason 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 Terminated
Dermoplast FIRST AID ANTIBACTERIAL SPRAY
Reason Subpotent Drug: Low assay observed in one of the two active ingredients during stability testing.
Class III · Low risk Terminated
Bd-102 Nf
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk Terminated
Avicel PH-200 NF
Reason Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.