Minolira extended-release tablets recalled over manufacturing violations

Recall date

April 23, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

EPI Health, LLC recalls minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Labor…

Recall number

D-0475-2024

FDA classification

Class II

Brand / firm

EPI Health, LLC

Sold / distributed

US Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.