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.
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
Lot numbers, UPCs & expiration codes
211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1165-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 14, 2014
- FDA report date
- Mar 26, 2014
- Quantity
- 30,800 Kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Traxx International Corp
Original FDA data
Every field from FDA enforcement report D-1165-2014, exactly as published.
Show all FDA fields
- City
- Pine Brook
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 67661
- Address
- 26 Chapin Rd
- Address (line 2)
- Suite 1103
- Code information
- 211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322
- Postal code
- 07058-9210
- Report date
- Mar 26, 2014
- Product type
- Drugs
- Recall number
- D-1165-2014
- Classification
- Class II
- Recalling firm
- Traxx International Corp
- Product quantity
- 30,800 Kg
- Termination date
- Sep 26, 2017
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 14, 2014
- Initial firm notification
- Telephone
- Center classification date
- Mar 18, 2014