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Recall Observatory FDA recall evidence

Drug product

Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109

D-0728-2016

February 02, 2016

Class III

Product summary

Firm
Isomeric Pharmacy Solution, LLC
Event
Event 73207
Status
Terminated
Classification
Class III
Quantity
114 vials
Official record key
drug-enforcement:D-0728-2016

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.

Code information: Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015"

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled