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Recall Observatory FDA recall evidence

Drug product

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

D-0378-2025

March 24, 2025

Class II

Product summary

Firm
RemedyRepack Inc.
Event
Event 96627
Status
Ongoing
Classification
Class II
Quantity
1,858 30-count blister cards
Official record key
drug-enforcement:D-0378-2025

Official wording

Reason: CGMP Deviations

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

Distribution pattern: PA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations