FDA recall D-0812-2021

Aurobindo Pharma USA Inc. · Class II · drug

Product

Metoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99

Reason for recall

Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2021-09-09
Report date
2021-09-29
Termination date
2023-10-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0812-2021