FDA recall D-050-2013

Stat Rx USA · Class III · drug

Product

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

Reason for recall

Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."

Distribution

FL, PA, and VA.

Key facts

Status
Terminated
Initiation date
2012-06-18
Report date
2012-11-21
Termination date
2013-01-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-050-2013