Reported Feb 5, 2020 · Terminated

Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai,…

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: 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, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
Lot codes and dates
  • Lots
    • BB70
    • BB71 Exp. May 2020
Amount recalled
6288 16 oz bottles

Where it was sold

  • Nationwide

Why it was recalled

Subpotent: Out of specification for assay at the 12-month time point.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 3, 2021 · Data as of Sep 19, 6:34 PM UTC

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