FDA recall D-1548-2022

Product

Rifampin Capsules, USP, 300 mg, a) 30-count bottle (NDC 61748-018-30), b) 60-count bottle (NDC 61748-018-60), c) 100-count bottle (NDC 61748-018-01), Rx only, Distributed by: Akorn Operating Company, LLC, Gurnee, IL 60031.

Reason for recall

Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).

Distribution

USA Nationwide and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2022-09-21

Report date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1548-2022