Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38...
FDA Recall #D-0167-2021 — Class II — December 7, 2020
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.
Recalling Firm
AVKARE Inc. — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
38715 bottles
Distribution
Nationwide within the U.S.
Code Information
Lot: 36884 Exp. 03/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated