The Recall Desk

FDA (Drugs) recall action 86940

AVKARE Inc. recalled 2 products on 2020-12-23

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2020-12-23
Critical
1
Units
53,083

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–2 of 2

  • ModerateFDA (Drugs)··2020-12-23

    AvKARE Recalls Sildenafil Tablets Due to Packaging Mix-Up with Trazodone

    AvKARE Inc. is recalling 38,715 bottles of Sildenafil 100 mg tablets because they were inadvertently packaged with trazodone at a third-party facility.

    Product
    Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2020-12-23

    AvKare Recalls Trazodone Hydrochloride Tablets Due to Sildenafil Packaging Mix-Up

    AvKare Inc. is recalling 14,368 bottles of Trazodone Hydrochloride Tablets 100 mg because they were inadvertently packaged with sildenafil.

    Product
    TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-834-10
    Category
    Distribution
    0 states