AVKARE LLC: Drug Recall

Recall #D-0091-2023 · 12/22/2022

Class II: Risk

Recall Details

Recall Number: D-0091-2023
Classification: Class II
Product Type: Drug
Recalling Firm: AVKARE LLC
Status: Completed
Date Initiated: 12/22/2022
Location: Pulaski, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1237 cartons

Reason for Recall

Failed impurities/degradation specifications: Out of specification for unknown impurities.

Product Description

Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-363-15

Distribution Pattern

USA Nationwide

Other Recalls by AVKARE LLC

Class II: Risk 08/11/2023

Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class II: Risk 08/11/2023

Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsaicin Cream 0.025% but contain correctly labeled tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Class III: Low Risk 06/13/2023

Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

View all recalls by AVKARE LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.