Why it was recalled
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Product description
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Lot numbers, UPCs & expiration codes
Lot # 639000, Exp. 10/31/2021
Where it was sold
United States including Puerto Rico
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-1378-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 23, 2020
- FDA report date
- Jul 15, 2020
- Quantity
- 14,760 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-1378-2020, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 85888
- Address
- 7265 Ulmerton Rd
- Code information
- Lot # 639000, Exp. 10/31/2021
- Postal code
- 33771-4809
- Report date
- Jul 15, 2020
- Product type
- Drugs
- Recall number
- D-1378-2020
- Classification
- Class III
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 14,760 bottles
- Termination date
- Sep 28, 2022
- Reason for recall
- Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
- Distribution pattern
- United States including Puerto Rico
- Recall initiation date
- Jun 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2020