FDA recall D-841-2013

Sanofi US · Class II · drug

Product

Rifadin, Rifampin capsules, 150 mg, packaged in 30-count bottle, Rx only, Mfd. for Sanofi-Aventis, U.S., LLC, Bridgewater, NJ 08807, NDC 0068-0510-30

Reason for recall

Subpotent drug: low fill volume in some of the capsules

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2013-03-07
Report date: 2013-08-14
Termination date: 2014-03-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bridgewater, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-841-2013