Reported Dec 26, 2018 · Terminated
NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose…
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 500,000 Units/5mL, unit dose 5ml cups, packaged in a) 50 unit dose cups (10x5ml unit dose cups per tray, 5 trays per case) NDC 66689-037-50; b) 100 unit dose cups (10x5ml unit dose cups per tray, 10 trays per case) NDC 66689-037-99. Rx Only, Manufactured by VistaPharm, Inc. Largo, FL 33771
- Lot codes and dates
- Lots
a) 505300 Exp. Dec 2018522200 Exp. Apr 2019534400 Exp. Jul 2019539000 Exp. Aug 2019543400 Exp. Sep 2019b) 523600522200X Exp. Apr 2019535500 Exp. Jul 2019540700 Exp. Aug 2019543300 Exp. Sep 2019550100 Exp. Oct 2019
- Lots
- Amount recalled
- 4,065,550 5 ml cups
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed Impurities/Degradation Specifications:Out of specification for impurities.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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