Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification for impurities.
Product description
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Lot numbers, UPCs & expiration codes
Lots: a) 505300 Exp. Dec 2018; 522200 Exp. Apr 2019; 534400 Exp. Jul 2019; 539000 Exp. Aug 2019; 543400 Exp. Sep 2019; b) 523600, 522200X Exp. Apr 2019; 535500 Exp. Jul 2019; 540700 Exp. Aug 2019; 543300 Exp. Sep 2019; 550100 Exp. Oct 2019.
Where it was sold
Nationwide in the USA and 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-0348-2019
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Nov 30, 2018
- FDA report date
- Dec 26, 2018
- Quantity
- 4,065,550 5 ml cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0348-2019, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 81684
- Address
- 7265 Ulmerton Rd
- Code information
- Lots: a) 505300 Exp. Dec 2018; 522200 Exp. Apr 2019; 534400 Exp. Jul 2019; 539000 Exp. Aug 2019; 543400 Exp. Sep 2019; b) 523600, 522200X Exp. Apr 2019; 535500 Exp. Jul 2019; 540700 Exp. Aug 2019; 543300 Exp. Sep 2019; 550100 Exp. Oct 2019.
- Postal code
- 33771-4809
- Report date
- Dec 26, 2018
- Product type
- Drugs
- Recall number
- D-0348-2019
- Classification
- Class III
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 4,065,550 5 ml cups
- Termination date
- Nov 25, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications:Out of specification for impurities.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Nov 30, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2019