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

FDA recall notice · announced June 13, 2018 · Pharmaceutical Associates

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

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.

Notes

Distribution: Nationwide
Lot/code information: Lot: B5B8 Exp. 07/2019
Quantity: 275400 cups
Status: Terminated
Products in this recall event:
- 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 (D-0865-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.