Nystatin Oral Suspension recall: Impurity Out of Spec
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by…
Why was Nystatin Oral Suspension recalled?
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
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?
Lot # 639000, Exp. 10/31/2021
- Product
- Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by…
- Recalling firm
- VistaPharm, Inc.
- Quantity
- 14,760 bottles
- Distribution
- United States including Puerto Rico
- Recall date
- July 15, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)