Recalls / Class III
Class IIID-0019-2021
Product
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,
- Affected lot / code info
- Lots: 638800 Exp 10/21
Why it was recalled
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 14,244 16 oz bottles
- Distribution pattern
- Distributed Nationwide in the USA including Puerto Rico
Timeline
- Recall initiated
- 2020-09-25
- FDA classified
- 2020-10-05
- Posted by FDA
- 2020-10-14
- Terminated
- 2022-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0019-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.