Reported Oct 14, 2020 · Terminated
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL)…
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?
NYSTATIN ORAL SUSPENSIONUSP 100000
- units per mL ContainsAlcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480
- mL) Manufactured by
VistaPharmInc. Largo FL 33771USA NDC 66689-008-16 UPC 6668900816
- Lot codes and dates
- Lots638800 Exp 10/21
- Amount recalled
- 14,244 16 oz bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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