FDA Drug recall D-0411-2025
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701
- FDA Drug
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701 by Remedyrepack, citing CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0411-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-22 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Remedyrepack |
| Distribution | FL, PA, VA |
Product
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Reason
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Identifiers
| code_info | Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0411-2025%22
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