# FDA recall D-0474-2024

> **EPI Health, LLC** · Class II · drug recall initiated 2024-04-23.

## Product

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.

## 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

- **Recall number:** D-0474-2024
- **Recalling firm:** EPI Health, LLC
- **Classification:** Class II
- **Product type:** drug
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0474-2024

## Citation

> AI Analytics. FDA recall D-0474-2024. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0474-2024. Source: US FDA. Licensed CC0.

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