Why it was recalled
Presence of Foreign Substance: potential presence of plastic particles.
Product description
Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
Lot numbers, UPCs & expiration codes
Lot #: 23701.158A, EXP 10/31/18
Where it was sold
Nationwide in the US
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-1059-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 17, 2017
- FDA report date
- Aug 16, 2017
- Quantity
- 9,816 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- X-Gen Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1059-2017, exactly as published.
Show all FDA fields
- City
- Horseheads
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 77834
- Address
- 300 Daniel Zenker Dr
- Code information
- Lot #: 23701.158A, EXP 10/31/18
- Postal code
- 14845-1014
- Report date
- Aug 16, 2017
- Product type
- Drugs
- Recall number
- D-1059-2017
- Classification
- Class II
- Recalling firm
- X-Gen Pharmaceuticals Inc.
- Product quantity
- 9,816 bottles
- Termination date
- Sep 5, 2018
- Reason for recall
- Presence of Foreign Substance: potential presence of plastic particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 17, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 9, 2017