Why it was recalled
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Product description
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Lot numbers, UPCs & expiration codes
Lots: 638800 Exp 10/21
Where it was sold
Distributed Nationwide in the USA 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-0019-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Sep 25, 2020
- FDA report date
- Oct 14, 2020
- Quantity
- 14,244 16 oz bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-0019-2021, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 86486
- Address
- 7265 Ulmerton Rd
- Code information
- Lots: 638800 Exp 10/21
- Postal code
- 33771-4809
- Report date
- Oct 14, 2020
- Product type
- Drugs
- Recall number
- D-0019-2021
- Classification
- Class III
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 14,244 16 oz bottles
- Termination date
- Sep 28, 2022
- Reason for recall
- Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
- Distribution pattern
- Distributed Nationwide in the USA including Puerto Rico
- Recall initiation date
- Sep 25, 2020
- Initial firm notification
- Letter
- Center classification date
- Oct 5, 2020