Traxx Recalls Guaifenesin API Powder Due to Foreign Matter
Traxx International Corp is recalling Guaifenesin API powder because it may contain polyethylene fibers from a sifting screen.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is the presence of foreign matter (polyethylene fibers) in an API powder intended for manufacturing, which is a significant quality issue but does not meet the criteria for Severe or Critical severity as no injuries or deaths are reported.
Plain-English summary
Traxx International Corp is recalling 30,800 kg of Guaifenesin USP, 50 Kg Drums (NDC 60203-1001). The product is being recalled due to the possibility that it contains polyethylene fibers from a screen used to sift the Guaifenesin.
The affected product is distributed nationwide. The recall includes lots with the following codes: 211J3291, 211J3292, 211K3293, 211K3294, 211K3295, 211K3297, 211K3298, 211K3299, 211K3301, 211K3302, 211K3315, 211K3321, and 211K3322. The product is labeled "Caution: For Manufacturing, Processing, or Repacking" and is manufactured by Delta Synthetic Co., Ltd. in Taiwan (ROC).
Consumers and businesses should check their inventory for the specific lot codes listed above. If the product is found, it should be removed from use and returned to the supplier or disposed of according to local regulations.
The recalled product
- 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
- Manufacturer
- Traxx International Corp
- Hazard
Distribution
Distributed nationwide across the United States.
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