Reported Jul 15, 2020 · Terminated
Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL…
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 500000 units/5mL CupDelivers 5 mLRx Only
- Manufactured byVistaPharm, Largo, FL 33771
- a) NDC 66689-037-50 (individual cup NDC
66689-037-01)b) 66689-037-99
- Lot codes and dates
Lot #: a) 619800Exp. 12/31/2020626200Exp. 01/31/2021b) 619800XExp. 12/31/2020626200XExp. 01/31/2021
- Amount recalled
- 380,700 cups
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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