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
Reported: June 13, 2018 Initiated: May 29, 2018 #D-0865-2018
Product Description
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
Reason for Recall
Resuspension problems: Out of specification for appearance and resuspendability.
Details
- Recalling Firm
- Pharmaceutical Associates Inc
- Units Affected
- 275400 cups
- Distribution
- Nationwide
- Location
- Greenville, SC
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Pharmaceutical Associates Inc. Units affected: 275400 cups.
Why was this product recalled? ▼
Resuspension problems: Out of specification for appearance and resuspendability.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 13, 2018. Severity: Low. Recall number: D-0865-2018.
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