FDA recall D-0504-2024

Product

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

US Nationwide.

Key facts

Status

Ongoing

Initiation date

2024-05-01

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0504-2024