Drug product
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
D-0248-2018
Product summary
- Event
- Event 78990
- Status
- Terminated
- Classification
- Class III
- Quantity
- 45,875 bottles
- Official record key
drug-enforcement:D-0248-2018
Official wording
Reason: Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Code information: Lot Numbers: 17080591 and 17080619, exp 07/19; 17110907 and 17110908, exp 10/19; and 17120986, exp 11/19
Distribution pattern: Nationwide
Derived failure modes
-
Labeling or packaging
Labeling; Label Error