Reported Jun 19, 2019 · Terminated

Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton,…

Torrent Pharma Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Torrent Pharma Inc · 2091 Hartel Ave · Levittown, PA · 19057-4506

Is this the product you have?

  • Anu-Med brand of Hemorrhoidal Suppositories (Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12 suppositories per carton
  • NDC
    • 0904-7688-22
    • Distributed by Major Pharmaceuticals
    • Livonia MI 48152
Lot codes and dates
    • Lot #s: 17L008
    • Exp. 05/2019
    • 17M011
    • 17M037
    • Exp. 06/2019
    • 18A015
    • Exp. 07/2019
    • 18B012
    • 18B023
    • Exp. 08/2019
    • 18K023
    • 18K029
    • Exp. 04/2020
    • 18L014
    • Exp. 05/2020
    • 19A001
    • Exp. 06/2020
Amount recalled
177,408 bottles

This recall covers 41 products

The agency filed one notice per product. You are reading one of them; the other 40 are below.

28 more are in the archive.

Why it was recalled

cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Oct 6, 2020 · Data as of Sep 19, 6:37 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.