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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