Reported Jun 7, 2017 · Terminated
Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000…
VistaPharm, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: VistaPharm, Inc. · 7265 Ulmerton Rd · Largo, FL · 33771-4809
Is this the product you have?
3 of 3 products
| # | Product as published |
|---|---|
| 1 | 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in |
| 2 | 50 count unit dose cups/case (NDC 66689-037-50) and |
| 3 | 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771. |
- Lot codes and dates
a) Lot #: 431300Exp. 01/2018b) Lot #: 434000432500Exp. 07/2017462200Exp. 02/2018 c) Lot #: 443800445500Exp. 09/2017460500461500Exp. 01/2018
- Amount recalled
- 2,208,500 cups/18696 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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