FDAFDA · Food and drugs·Recall number D-1060-2020
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
Published April 1, 2020 · Recall initiated: March 19, 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: Low out-of-specification results for assay testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Distributor
- Nationwide in the USA.
- UPC
- 0301210810022
- Lot
- Lot: BE85, Exp. 11/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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