FDA Drug recall D-1165-2014
Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg
- FDA Drug
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg by Traxx International, citing presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1165-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-01-14 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Traxx International |
| Distribution | US |
Product
Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
Reason
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Identifiers
| code_info | 211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1165-2014%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.