FDA recall D-0362-2022

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

Reason for recall

Complaint received of foreign matter (metal) embedded in tablet.

Distribution

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

Key facts

Status

Terminated

Initiation date

2021-12-31

Report date

2022-01-19

Termination date

2022-11-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ambernath, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0362-2022