FDA recall D-1057-2020

Product

Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01

Reason for recall

Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-03-23

Report date

2020-04-01

Termination date

2021-07-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1057-2020