Drug product
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
D-0824-2020
Product summary
- Event
- Event 84712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6288 16 oz bottles
- Official record key
drug-enforcement:D-0824-2020
Official wording
Reason: Subpotent: Out of specification for assay at the 12-month time point.
Code information: Lots: BB70, BB71 Exp. May 2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
Subpotent