Home / Recalls / EPI Health, LLC / D-0120-2020

D-0120-2020 Class III Terminated

Recalled by EPI Health, LLC — Charleston, SC

Recall Details

Product Type
Drugs
Report Date
October 2, 2019
Initiation Date
August 26, 2019
Termination Date
August 18, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,626 5-count bottles

Product Description

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.

Reason for Recall

Failed Dissolution Specifications:

Distribution Pattern

Firm recalling only from EPI Field Representatives.

Code Information

Lot# T900093, Exp 11/2020

Other recalls by EPI Health, LLC

  • D-0474-2024 Class II — minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bo (April 23, 2024)
  • D-0475-2024 Class II — minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bo (April 23, 2024)
  • D-0473-2024 Class II — Cloderm (clocortolone pivalate) Cream, 0.1%, Rx Only, For Topical Use Only, Net (April 23, 2024)