Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

Recall Number: D-0068-2021

Firm: Nostrum Laboratories Inc

Classification: Class II

Status: Ongoing

Report Date: 20201111

Initiation Date: 20201023

Termination Date:

Reason for Recall

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

Product Description

Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-055-01

DrugLabelsHub provides FDA drug labeling information for reference only. Always consult a healthcare professional.

Data source: openFDA · Updated regularly