Guaifenesin USP (Traxx) – foreign matter contamination (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Traxx International Corp
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322
Traxx International Corp is recalling Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processin due to Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a scree. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026