Drug product
Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (473 mL) bottle, Rx ONLY, pai Pharmaceutical Associates, Inc., Greenville, SC 29605; NDC 0121-0810-16.
D-1060-2020
Product summary
- Event
- Event 85302
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7416 bottles
- Official record key
drug-enforcement:D-1060-2020
Official wording
Reason: SubPotent Drug: Low out-of-specification results for assay testing.
Code information: Lot: BE85, Exp. 11/2020
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Potency or specification failure
SubPotent