FDA recall D-0291-2015

Sandoz Incorporated · Class III · drug

Product

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

Reason for recall

Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.

Distribution

AZ

Key facts

Status: Terminated
Initiation date: 2014-12-05
Report date: 2014-12-17
Termination date: 2015-06-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Broomfield, CO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0291-2015