Nystatin Oral Suspension recall: Impurity Out of Spec
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,
Why was Nystatin Oral Suspension recalled?
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lots: 638800 Exp 10/21
- 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,
- Recalling firm
- VistaPharm, Inc.
- Quantity
- 14,244 16 oz bottles
- Distribution
- Distributed Nationwide in the USA including Puerto Rico
- Recall date
- October 14, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)