FDAFDA · Food and drugs·Recall number D-0824-2020
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Published February 5, 2020 · Recall initiated: January 14, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent: Out of specification for assay at the 12-month time point.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN
- Manufacturer
- Pharmaceutical Associates Inc
- Distributor
- Distributed Nationwide in the US
- UPC
- 0301210810022
- Lot
- Lots: BB70, BB71 Exp. May 2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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