Reported Jun 19, 2019 · Terminated

Robafen Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle, NDC:…

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 Cough Formula Expectorant (guaifenesin USP 200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle
NDC
- 0904-0061-00
- b) One Pint ( 473 mL) bottle
NDC
- 0904-0061-16
- Distributed by Major Pharmaceuticals
- Livonia MI 48152

Lot codes and dates: Lot #s: a) 17F003
Exp. 06/2019
17J011
Exp. 09/2019
17K018
17K020
Exp. 10/2019
17M014
17M034
Exp. 12/2019
18A035
Exp. 01/2020
18B022
18B027
Exp. 02/2020
18C036
Exp. 03/2020
18D009
18D024
Exp. 04/2020. b) 17G018
Exp. 07/2019
17H001
17H010
17H014
Exp. 08/2019
17J009
Exp. 09/2019
17K023
Exp. 10/2019
17L006
17L025
Exp. 11/2019
17M025
17M034
Exp. 12/2019
18A005
18A012
18A016
Exp. 01/2020
18B020
Exp. 02/2020
18C023
18C031
Exp. 03/2020
18E017
Exp. 05/2020
18G005
18G022
Exp. 07/2020
18H021
18H026
Exp. 08/2020
18J003Exp. 09/2020
Amount recalled: 984,888 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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