FDAFDA · Food and drugs·Recall number D-1494-2020
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
Published August 19, 2020 · Recall initiated: August 4, 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 drug: Out of specification for assay at the 15-month test interval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Distributor
- Nationwide USA
- UPC
- 0301210810022
- Lot
- Lot: B973, Exp 11/20
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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