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Recall Observatory FDA recall evidence

Drug product

Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.

D-0695-2017

April 17, 2017

Class III

Product summary

Firm
Fagron, Inc
Event
Event 77018
Status
Terminated
Classification
Class III
Quantity
Unavailable
Official record key
drug-enforcement:D-0695-2017

Official wording

Reason: Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.

Code information: Lot #: 17C01-U07-036096, Exp. 5/1/2020

Distribution pattern: Nationwide within US

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Error on Declared Strength: Error