FDA-Drug2024-05-01Class II
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.
EPI Health, LLC
Hazard
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.
Sold states
US Nationwide
Affected count
5664 bottles
Manufactured in
174 Meeting St Ste 200, N/A, Charleston, SC, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2024Don't want to check this manually?
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