Drug 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
D-1165-2014
Product summary
- Event
- Event 67661
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30,800 Kg
- Official record key
drug-enforcement:D-1165-2014
Official wording
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.
Code information: 211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Matter