D-1165-2014 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 26, 2014
- Initiation Date
- January 14, 2014
- Termination Date
- September 26, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30,800 Kg
Product Description
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 for Recall
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.
Distribution Pattern
Nationwide
Code Information
211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322