Reported Jul 15, 2020 · Terminated
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before…
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 Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only
- Manufactured byVistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16
- Lot codes and dates
Lot # 639000Exp. 10/31/2021
- Amount recalled
- 14,760 bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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