FDA recall D-0120-2020

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.

Reason for recall

Failed Dissolution Specifications:

Distribution

Firm recalling only from EPI Field Representatives.

Key facts

Status

Terminated

Initiation date

2019-08-26

Report date

2019-10-02

Termination date

2021-08-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Charleston, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0120-2020