FDA recall D-1165-2014

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 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

Nationwide

Key facts

Status

Terminated

Initiation date

2014-01-14

Report date

2014-03-26

Termination date

2017-09-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pine Brook, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1165-2014