Reported Jun 19, 2019 · Terminated

Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP…

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

Robafen DM Cough Sugar-Free Clear Cough Expectorant (Dextromethorphan HBr, USP 20 mg), Expectorant (Guaifenesin, USP 200 mg in each 2 teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle
NDC
- 0904-6306-20
- Distributed by Major Pharmaceuticals
- Livonia MI 48152

Lot codes and dates: Lot #s: 17E016
17E017
Exp. 05/2019
17F023
17F023A
Exp. 06/2019
17L018
17L029
17L030
17L031
Exp. 11/2019
17M035
Exp. 12/2019
18B002
18B014
18B035
Exp. 02/2020
18C002
18C019
Exp. 03/2020
18D013
Exp. 04/2020
Amount recalled: 262,008 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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