FDA Drug recall D-1350-2019
Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Robafen AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6… 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-1350-2019 |
| 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 AC Oral Solution (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC:0904-6479-16, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152.
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| code_info | Lot #s: 17M003, Exp. 12/2019; 18A009; 18A010, Exp. 01/2020; 18B024, Exp. 02/2020; 18F021; Exp. 06/2020; 18G009; 18G020,…Lot #s: 17M003, Exp. 12/2019; 18A009; 18A010, Exp. 01/2020; 18B024, Exp. 02/2020; 18F021; Exp. 06/2020; 18G009; 18G020, Exp. 07/2020; 18K005; 18K011; Exp. 10/2020. |
|---|
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-1350-2019%22
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