Drug product
Xanax (Alprazolam) USP, CIV, 0.5 mg tablets , 10 x 10 blister cards per carton, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08805, NDC 63739-669-10
D-1527-2016
Product summary
- Event
- Event 75215
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,492 unit cartons of 10 x 10 blister cards
- Official record key
drug-enforcement:D-1527-2016
Official wording
Reason: Labeling: Missing Label-Primary packaging label (i.e. blister card) is blank and contains no product information (e.g. product name, strength, lot number, expiry).
Code information: Lot #: 0111512; Exp. 08/17
Distribution pattern: CO, IL, LA, OH
Derived failure modes
-
Labeling or packaging
Labeling: Missing