PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: December 23, 2020 Initiated: December 7, 2020 #D-0167-2021

Product Description

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.

Details

Recalling Firm
AVKARE Inc.
Units Affected
38715 bottles
Distribution
Nationwide within the U.S.
Location
Pulaski, TN

Frequently Asked Questions

What product was recalled?
Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.. Recalled by AVKARE Inc.. Units affected: 38715 bottles.
Why was this product recalled?
Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Which agency issued this recall?
This recall was issued by the FDA Drug on December 23, 2020. Severity: Moderate. Recall number: D-0167-2021.