Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufac...
FDA Recall #D-0067-2021 — Class II — October 23, 2020
Product Description
Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 count bottles, Rx Only. Manufactured by: Nostrum Laboratories, Inc. Kansas City, MO 64120. NDC 29033-056-01
Reason for Recall
CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Recalling Firm
Nostrum Laboratories Inc — Kansas City, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
12,967 bottles
Distribution
Nationwide
Code Information
MET200101, MET200301 EXP 05/2022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated