Reported Aug 18, 2021 · Terminated
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL)…
PAI Holdings, LLC. dba Pharmaceutical Associates Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: PAI Holdings, LLC. dba Pharmaceutical Associates Inc · 1700 Perimeter Rd · Greenville, SC · 29605-5252
Is this the product you have?
- 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 byPharmaceutical Associates, Inc. Greenville, SC 29605
- Lot codes and dates
- Lots
a) C98FC990 Exp. 30SEP2022C9C2 Exp. 31OCT2022b) C9E1 Exp. 31OCT2022
- Lots
- Amount recalled
- a) 1002 cases (12 bottles/case); b) 458 cases (24 bottles/case)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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