D-0362-2022 Class II Terminated

Recalled by Rubicon Research Private Limited — Ambernath, N/A

FDA drug recall D-0362-2022 was initiated by Rubicon Research Private Limited on December 31, 2021 and is designated Class II. Reason for recall: Complaint received of foreign matter (metal) embedded in tablet. The recall status is terminated (terminated November 4, 2022). Affected quantity: 3,684 1000-count bottles.

Recall Details

Product Type
Drugs
Report Date
January 19, 2022
Initiation Date
December 31, 2021
Termination Date
November 4, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,684 1000-count bottles

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.

Distribution Pattern

Product was distributed to one distributor who may have distributed the product further nationwide.

Code Information

Batch # 210211H1, Exp. date FEB 2024