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Recall Observatory FDA recall evidence

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

June 18, 2012

Class III

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

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-up