Nostrum Laboratories Inc: Drug Recall

Recall #D-0249-2021 · 01/25/2021

Class II: Risk

Recall Details

Recall Number: D-0249-2021
Classification: Class II
Product Type: Drug
Recalling Firm: Nostrum Laboratories Inc
Status: Ongoing
Date Initiated: 01/25/2021
Location: Kansas City, MO, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7071 bottles

Reason for Recall

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Nostrum Laboratories, Inc., Kansas City, MO 64120. NDC: 29033-056-01

Distribution Pattern

Nationwide

Other Recalls by Nostrum Laboratories Inc

Class II: Risk 07/11/2025

CGMP Deviations: The recalling firm filed for Chapter 11 in September 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
Class II: Risk 01/04/2021

CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level

View all recalls by Nostrum Laboratories Inc →

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.