Why it was recalled
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
Product description
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
Lot numbers, UPCs & expiration codes
a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.
Where it was sold
Nationwide in the US 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-0869-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 17, 2017
- FDA report date
- Jun 7, 2017
- Quantity
- 2,208,500 cups/18696 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0869-2017, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77319
- Address
- 7265 Ulmerton Rd
- Code information
- a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.
- Postal code
- 33771-4809
- Report date
- Jun 7, 2017
- Product type
- Drugs
- Recall number
- D-0869-2017
- Classification
- Class III
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 2,208,500 cups/18696 bottles
- Termination date
- Jan 13, 2020
- Reason for recall
- Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.
- Distribution pattern
- Nationwide in the US and Puerto Rico
- Recall initiation date
- May 17, 2017
- Initial firm notification
- Letter
- Center classification date
- May 31, 2017