Reported Jun 13, 2018 · Terminated

Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only,…

Pharmaceutical Associates Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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 · 201 Delaware St · Greenville, SC · 29605-5823

Is this the product you have?

  • Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Lot codes and dates
  • LotB5B8 Exp. 07/2019
Amount recalled
275400 cups

Where it was sold

  • Nationwide

Why it was recalled

Resuspension problems: Out of specification for appearance and resuspendability.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Jan 13, 2020 · Data as of Sep 19, 7:12 PM UTC

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