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Recall Observatory FDA recall evidence

Drug product

Sildenafil 200 mg Troche (Clinic)

D-0814-2020

December 18, 2019

Class II

Product summary

Firm
MPRX, Inc. dba Medical Park Pharmacy
Event
Event 84527
Status
Terminated
Classification
Class II
Quantity
1 bottle
Official record key
drug-enforcement:D-0814-2020

Official wording

Reason: Labeling: Incorrect or missing lot and/or expiration date. Products were compounded using expired components.

Code information: Lot: 61392:42 Use by: 05/05/2020

Distribution pattern: TX

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or missing