Home / Recalls / EPI Health, LLC / D-0474-2024

D-0474-2024 Class II Terminated

Recalled by EPI Health, LLC — Charleston, SC

Recall Details

Product Type
Drugs
Report Date
May 1, 2024
Initiation Date
April 23, 2024
Termination Date
September 12, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12808 bottles

Product Description

minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.

Reason for Recall

CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Distribution Pattern

US Nationwide

Code Information

lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025

Other recalls by EPI Health, LLC

  • 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)
  • D-0120-2020 Class III — minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician (August 26, 2019)