Drug product
BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite 400, Princeton, NJ 08805, NDC: 63739-706-10
D-0928-2017
Product summary
- Event
- Event 77411
- Status
- Terminated
- Classification
- Class III
- Quantity
- 942 cartons
- Official record key
drug-enforcement:D-0928-2017
Official wording
Reason: Failed Moisture Limits: Product tested out-of-specification for moisture content.
Code information: Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18
Distribution pattern: Nationwide in the US
Derived failure modes
-
Potency or specification failure
out-of-specification