FDA Drug recall D-0475-2024
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, IND…
- FDA Drug
- Class II
- terminated
- Published 2024-05-01
On 2024-05-01 the FDA classified a Class II recall of minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, IND… by Epi Health, citing CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are pur….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0475-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-04-23 |
| Published | 2024-05-01 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Epi Health |
| Distribution | US |
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
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.
Identifiers
| code_info | lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0475-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.