Reported Jun 19, 2019 · Terminated

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle,…

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

Cough Syrup (Guaifenesin Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz. bottle
NDC0536-0825-85, Distributed by Rugby Laboratories, Livonia, MI 48152

Lot codes and dates: Lot #s: 17F022
Exp. 06/2019
17G027
Exp. 07/2019
17H021
17H021A
Exp. 08/2019
17J008
Exp. 09/2019
17L001
Exp. 11/2019
17M015
Exp. 12/2019
18A018
Exp. 01/2020
18B003
18B008
Exp. 02/2020
18C012
Exp. 03/2020
18D005
Exp. 04/2020
18F008
18F043
Exp. 06/2020
18G025
18H004
Exp. 07/2020
18H007
18H016
Exp. 08/2020
Amount recalled: 249,744 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.

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