EPI Health, LLC recalls minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only,…

Recall date

August 26, 2019

Source

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

Recall number

D-0120-2020

FDA classification

Class III

Brand / firm

EPI Health, LLC

Sold / distributed

Firm recalling only from EPI Field Representatives.

Why it was recalled

Failed Dissolution Specifications:

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.