FDA recall D-0167-2021

AVKARE Inc. · Class II · drug

Product

Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.

Reason for recall

Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.

Distribution

Nationwide within the U.S.

Key facts

Status
Terminated
Initiation date
2020-12-07
Report date
2020-12-23
Termination date
2023-10-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2021