Nystatin Oral Suspension recall: Impurity Out of Spec
Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
Why was Nystatin Oral Suspension recalled?
Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months.
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 # 240200, 243000, 244800, 245600, 250800 and 253600. Exp 06/13.
- Product
- Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Recalling firm
- VistaPharm, Inc.
- Quantity
- 1,707,050 cups / 5ml ea.
- Distribution
- Nationwide.
- Recall date
- August 28, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)