August 2019 FDA Recall Drug by Epi Health, Llc
D-0120-2020 - Failed Dissolution Specifications

This Class III drug recall was voluntarily initiated by Epi Health, Llc on August 26, 2019 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in Firm recalling only from EPI Field Representatives. and the recall is currently terminated.

Recall Number: D-0120-2020

Reason for Recall
Failed Dissolution Specifications:
Initiated
08-26-2019
Reported
10-02-2019
Quantity
1,626 5-count bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83809
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
EPI Health, 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.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Firm recalling only from EPI Field Representatives.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-18-2021
Product Description About Product Description
Full technical description of the product.
minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.

Batch or Lot Expiration Information

Lot# T900093, Exp 11/2020