Why it was recalled
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Product description
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
Lot numbers, UPCs & expiration codes
Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
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-1377-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 23, 2020
- FDA report date
- Jul 15, 2020
- Quantity
- 380,700 cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-1377-2020, 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 #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
- Postal code
- 33771-4809
- Report date
- Jul 15, 2020
- Product type
- Drugs
- Recall number
- D-1377-2020
- Classification
- Class III
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 380,700 cups
- 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 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.
- Distribution pattern
- United States including Puerto Rico
- Recall initiation date
- Jun 23, 2020
- Initial firm notification
- Letter
- Center classification date
- Jul 8, 2020