December 2021 FDA Recall Metoprolol Tartrate by Rubicon Research Private Limited (D-0362-2022 - Complaint received of foreign matter (metal) embedded in tablet.)
This Class II drug recall was voluntarily initiated by Rubicon Research Private Limited on December 31, 2021 for the product Metoprolol Tartrate. The FDA reported the reason for recall as complaint received of foreign matter (metal) embedded in tablet.. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0362-2022
Complaint received of foreign matter (metal) embedded in tablet.
12-31-2021
01-19-2022
3,684 1000-count bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Rubicon Research Private Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to one distributor who may have distributed the product further nationwide.
11-04-2022
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Batch# 210211H1, Exp. date FEB 2024
