FDA Drug recall D-1363-2019
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 165…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 165… 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-1363-2019 |
| 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
Guaifenesin AC Cough Syrup (Guaifenesin and Codeine Phosphate Oral Solution, USP) 100 mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by Rising Pharmaceuticals Inc., Saddle Brook, NJ 07663
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| code_info | Lot #s: 17H002; 17H005; 17H006; 17H007; 17H026; 17H027, Exp. 08/2019; 17J010; 17J013, Exp. 09/2019; 17K014; 17K015, Exp…Lot #s: 17H002; 17H005; 17H006; 17H007; 17H026; 17H027, Exp. 08/2019; 17J010; 17J013, Exp. 09/2019; 17K014; 17K015, Exp. 10/2019; 17L015, Exp. 11/2019; 17M026, Exp. 12/2019; 18A028; 18A031, Exp. 01/2020; 18B026, Exp. 02/2020; 18E003, Exp. 05/2020. |
|---|
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-1363-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.