D-050-2013 Class III Terminated

Recalled by Stat Rx USA — Gainesville, GA

Recall Details

Product Type
Drugs
Report Date
November 21, 2012
Initiation Date
June 18, 2012
Termination Date
January 31, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
22 units

Product Description

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 Pattern

FL, PA, and VA.

Code Information

Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14