Reported Jun 19, 2019 · Terminated

Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd…

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

Cetirizine Hydrochloride Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only, 120 mL bottle, NDC 23155-292-51, Mfd for Heritage Pharmaceuticals Inc., Eatontown, NJ 07724.

Lot codes and dates: Lot #s: 17E021
17E023
17E040
17E042
Exp. 05/2019
17F017
Exp. 06/2019
17G030
17G033
Exp. 07/2019
17H013
Exp. 08/2019
17J007
17J024
Exp. 09/2019
17K003
17K011
Exp. 10/2019
17L016
17L022
Exp. 11/2019
17M001
17M021
17M030
Exp. 12/2019
18A027
18A037
Exp. 01/2020
18B001
Exp. 02/2020
18C005
18C006
18C007
Exp. 03/2020
Amount recalled: 1,126,404 bottles

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

28 more are in the archive.

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.

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

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

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.