Reported Jun 19, 2019 · Terminated

Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL)…

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

Extra Action Cough Syrup (Guaifenesin and Dextromethorphan HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle
NDC
- 0536-0970-97
- b) One Pint (473 mL) bottle
- 0536-0970-85
- Distributed by Rugby Laboratories
- Livonia
- MI 48152

Lot codes and dates: Lot #s: 17E034
Exp. 05/2019
17L023
Exp. 11/2019
17M027
17M027A
Exp. 12/2019
18A024
Exp. 01/2020
18B029
Exp. 02/2020
18C018
18C021
Exp. 03/2020
18E008
Exp. 05/2020
Amount recalled: 176,580 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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