D-050-2013 Class III Terminated
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