FDA recall D-0475-2024

EPI Health, LLC · Class II · drug

Product

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.

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

US Nationwide

Key facts

Status
Terminated
Initiation date
2024-04-23
Report date
2024-05-01
Termination date
2024-09-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Charleston, SC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2024