Reported Jun 19, 2019 · Terminated

Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD

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?

  • Cetirizine HCL Oral Solution, USP 1mg/mL, 4 oz - BULK, PLD
Lot codes and dates
    • Lot #s: 17E015
    • 17E024
    • 17E044
    • Exp. 05/2019
    • 17F018
    • Exp. 06/2019
    • 17G012
    • Exp. 07/2019
    • 17K024
    • Exp. 10/2019
    • 17M004
    • Exp. 12/2019
    • 18B017
    • Exp. 02/2020
    • 18H023
    • Exp. 08/2020
Amount recalled
361,260 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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Torrent Pharma Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

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, 8:07 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.