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Recall Observatory FDA recall evidence

Drug product

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

D-0892-2018

June 08, 2018

Class III

Product summary

Firm
Qualgen, LLC
Event
Event 80203
Status
Terminated
Classification
Class III
Quantity
2,940 pellets
Official record key
drug-enforcement:D-0892-2018

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date.

Code information: lot# C211 Exp. date 10/03/2018; C257 Exp. date 12/14/2018 and lot # D001 exp. date 01/02/19

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing