Reported Jun 19, 2019 · Terminated

Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz.,…

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

Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz
NDC
- 13668-580-10
- b) 32 FL. oz
NDC13668-580-12, Manufactured by Bio-Pharm Inc., Levittown PA 19057, Manufactured for Torrent Pharma Inc., Basking Ridge, NJ 07920

Lot codes and dates: Lot #s: a) 18K025
18K027
Exp. 10/2020
18L001
18L006
18L007
Exp. 11/2020
18M013
Exp. 12/2020
19A006
Exp. 01/2021. b) 18K027
Exp. 10/2020
19A006
Exp. 01/2021
Amount recalled: 96,060 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.