Drug product
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16
D-1494-2020
Product summary
- Event
- Event 86170
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7416 bottles
- Official record key
drug-enforcement:D-1494-2020
Official wording
Reason: Subpotent drug: Out of specification for assay at the 15-month test interval.
Code information: Lot: B973, Exp 11/20
Distribution pattern: Nationwide USA
Derived failure modes
-
Potency or specification failure
Subpotent