Reported Mar 26, 2014 · Terminated

Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking,…

Traxx International Corp.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Traxx International Corp · 26 Chapin Rd · Pine Brook, NJ · 07058-9210

Is this the product you have?

    • Guaifenesin USP
    • 50 Kg Drums
    • CAS No. 93-14-1
    • Reg. No. 05436
  • CautionFor Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001
Lot codes and dates
    • 211J3291
    • 211J3292
    • 211K3293
    • 211K3294
    • 211K3295
    • 211K3297
    • 211K3298
    • 211K3299
    • 211K3301
    • 211K3302
    • 211K3315
    • 211K3321
    • 211K3322
Amount recalled
30,800 Kg

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 26, 2017 · Data as of Sep 19, 7:53 PM UTC

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