FDAClass IIJune 10, 2020

Estriol USP Micronized recall: Impurity Out of Spec

Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02

Why was Estriol USP Micronized recalled?

Failed impurities/ degradation specifications: Out of specification for organic impurities.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #:17010401181119190927, EXP 12/2020, 1701040118111919092725200122, EXP.12/2020

Product
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02
Recalling firm
TRIOVA PHARMACEUTICALS LLC
Quantity
210 grams
Distribution
U.S.A. Nationwide
Recall date
June 10, 2020
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls