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,
D-050-2013
Product summary
- Firm
- Stat Rx USA
- Event
- Event 62940
- Status
- Terminated
- Classification
- Class III
- Quantity
- 22 units
- Official record key
drug-enforcement:D-050-2013
Official wording
Reason: Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Code information: Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
Distribution pattern: FL, PA, and VA.
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up