Drug Enforcement D-0474-2024

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.

Status

Terminated

Classification

Class II

Report Date

May 1, 2024

Termination Date

September 12, 2024

Product Information

Product description
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
Product quantity
12808 bottles
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.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
US Nationwide

Location & Firm

Recalling firm
EPI Health, LLC
Address
174 Meeting St Ste 200, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0474-2024
Event ID
94447
Recall initiation date
April 23, 2024
Center classification date
April 25, 2024
Code info
lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025
More code info
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