Reported Nov 21, 2012 · Terminated
Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake…
Stat Rx USA
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stat Rx USA · 2481 Hilton Dr · Gainesville, GA · 30501-6213
Is this the product you have?
- Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic
- forTobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05
- Lot codes and dates
- Lot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
- Amount recalled
- 22 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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