FDA Recall D-0411-2025

RemedyRePack Inc. · Indiana, PA

Class II Ongoing 387 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

Lot / code: Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.

Quantity: 23 bottles/30 count- 690 capsules

Reason for recall

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

Recall record

Recall number: D-0411-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Within U.S - PA, VA, FL.
Recall initiated: 2025-04-22
Classified by FDA Center: 2025-05-06
FDA published: 2025-05-14
Recalling firm: RemedyRePack Inc.
Firm location: Indiana, PA

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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