D-0928-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 5, 2017
- Initiation Date
- May 30, 2017
- Termination Date
- February 6, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 942 cartons
Product Description
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
Reason for Recall
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Distribution Pattern
Nationwide in the US
Code Information
Lot # 0113148, 0113149, 0113150, Exp: 04/18; 0113636, Exp: 06/18; 0114513, Exp: 10/18