FDAFDA · Food and drugs·Recall number D-0721-2021
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
Published August 18, 2021 · Recall initiated: July 29, 2021
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
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- NYSTATIN
- Manufacturer
- PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0301210868160
- Lot
- Lots: a) C98F, C990 Exp. 30SEP2022, C9C2 Exp. 31OCT2022; b) C9E1 Exp. 31OCT2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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