May 2020 FDA Recall Drug by Triova Pharmaceuticals Llc
D-1284-2020 - Failed impurities/ degradation specifications

This Class II drug recall was voluntarily initiated by Triova Pharmaceuticals Llc on May 15, 2020 for the product Drug. The FDA reported the reason for recall as failed impurities/ degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1284-2020

Reason for Recall
Failed impurities/ degradation specifications: Out of specification for organic impurities.
Initiated
05-15-2020
Reported
06-10-2020
Quantity
210 grams

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
85704
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
TRIOVA PHARMACEUTICALS LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S.A. Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-01-2023
Product Description About Product Description
Full technical description of the product.
Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa, OK 74103, NDC 71092-9977-02

Batch or Lot Expiration Information

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