FDA recall D-0813-2021

Product

Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

Nationwide within the USA

Key facts

Status

Terminated

Initiation date

2021-05-12

Report date

2021-09-29

Termination date

2022-08-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0813-2021