Class II · Moderate risk
Peripheral Parenteral Nutrition
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II drug recalls - moderate risk
Class II means the product may cause temporary or medically reversible harm, and serious harm is unlikely. It is by far the largest recall class - most potency, dissolution and labeling problems land here.
14,535 recalls, newest first.
Class II · Moderate risk
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class II · Moderate risk
clomiPRAMINE Hydrochloride Capsules USP 25 mg
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Class II · Moderate risk
Metoprolol Succinate Extended-Release Tablets
Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.
Class II · Moderate risk
Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Levothyroxine Sodium Tablets
Subpotent Drug: Assay below the approved specification
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Gabapentin Capsules
Defective container; blister packaging inadequately sealed.
Class II · Moderate risk
Lisdexamfetamine Dimesylate Capsules
Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 9 month long term stability station (25¿C, 60%RH).
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class II · Moderate risk
KIMMTRAK (tebentafusp-tebn)
Subpotent Drug
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCl Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.