FDA Drug recall D-1349-2019
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 ( 47…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of 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 ( 47… by Torrent Pharma, citing cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1349-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-21 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
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.
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| code_info | Lot #s: a) 17F003, Exp. 06/2019; 17J011, Exp. 09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A0…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. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1349-2019%22
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