FDA recall D-0928-2017

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

Reason for recall

Failed Moisture Limits: Product tested out-of-specification for moisture content.

Distribution

Nationwide in the US

Key facts

Status

Terminated

Initiation date

2017-05-30

Report date

2017-07-05

Termination date

2020-02-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0928-2017