Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, ...
FDA Recall #D-0362-2022 — Class II — December 31, 2021
Product Description
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate Limited Ambernath, Dist. Thane, 421506 India. NDC 52817-360-00
Reason for Recall
Complaint received of foreign matter (metal) embedded in tablet.
Recalling Firm
Rubicon Research Private Limited — Ambernath, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
3,684 1000-count bottles
Distribution
Product was distributed to one distributor who may have distributed the product further nationwide.
Code Information
Batch # 210211H1, Exp. date FEB 2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated