FDA Recall D-0378-2025

RemedyRepack Inc. · Indiana, PA

Class II Ongoing 416 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, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

Lot / code: Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025

Quantity: 1,858 30-count blister cards

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0378-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: PA
Recall initiated: 2025-03-24
Classified by FDA Center: 2025-04-18
FDA published: 2025-04-30
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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