Avkare LLC FDA Recalls

4 recalls on file across drugs, 0 of them Class I and 1 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 ppm Fluoride Plus Mild Cleaning System SpearmClass IIAug 11, 2023Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste	Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.	Class IIDrugs	Aug 11, 2023
Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NET WT. 2.1 OZ. (60g) NDC 50268-195-60, ManufClass IIAug 11, 2023Product mix-up: Cartons labeled Capsaicin Cream 0.025% may c	Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription	Class IIDrugs	Aug 11, 2023
Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NClass IIIJun 13, 2023Failed Impurities/Degradation Specifications: Out of specifi	Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.	Class IIIDrugs	Jun 13, 2023
Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 384Class IIDec 22, 2022Failed impurities/degradation specifications: Out of specifi	Failed impurities/degradation specifications: Out of specification for unknown impurities.	Class IIDrugs	Dec 22, 2022