Drug 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
D-0865-2018
Product summary
- Event
- Event 80190
- Status
- Terminated
- Classification
- Class III
- Quantity
- 275400 cups
- Official record key
drug-enforcement:D-0865-2018
Official wording
Reason: Resuspension problems: Out of specification for appearance and resuspendability.
Code information: Lot: B5B8 Exp. 07/2019
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification