FDAFDA · Food and drugs·Recall number D-050-2013
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,
Published November 21, 2012 · Recall initiated: June 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stat Rx USA
- Distributor
- FL, PA, and VA.
- Lot
- Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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