Drug product
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31
D-1035-2020
Product summary
- Event
- Event 85136
- Status
- Terminated
- Classification
- Class III
- Quantity
- 13008 bottles
- Official record key
drug-enforcement:D-1035-2020
Official wording
Reason: Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Code information: Lot #: 8672518, Exp 12/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing