Drug product
AMPICILLIN CAPSULES, USP, 250 mg, 500 count bottles, Rx only, Manufactured for: DAVA Pharmaceuticals, Inc., Fort Lee, NJ, By: Suir Pharma Ireland Ltd., Clonmel, Ireland, NDC: 67253-180-50
D-1350-2015
Product summary
- Event
- Event 71980
- Status
- Terminated
- Classification
- Class III
- Quantity
- 360 Bottles
- Official record key
drug-enforcement:D-1350-2015
Official wording
Reason: Labeling: Incorrect Or Missing Package Insert: Product is labeled with unapproved labeling.
Code information: Lot #: 52217, Expiry: 04/18
Distribution pattern: U.S. Including: OH
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect Or Missing