FDA recall D-1094-2017

Product

Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12

Reason for recall

Failed impurities/degradation specifications: Out of specification for a related compound C.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-07-19

Report date

2017-08-23

Termination date

2019-03-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1094-2017