Tobramycin Ophthalmic Oint recall: Labeling Error
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,
Why was Tobramycin Ophthalmic Oint recalled?
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
- 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,
- Recalling firm
- Stat Rx USA
- Quantity
- 22 units
- Distribution
- FL, PA, and VA.
- Recall date
- November 21, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)