April 2025 FDA Recall Drug by Remedyrepack Inc.
D-0411-2025 - CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

This Class II drug recall was voluntarily initiated by Remedyrepack Inc. on April 22, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations - products manufactured in a shared facility with ezetimibe tablets.. The product was distributed in Within U.S - PA, VA, FL. and the recall is currently ongoing.

Recall Number: D-0411-2025

Reason for Recall
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
Initiated
04-22-2025
Reported
05-14-2025
Quantity
23 bottles/30 count- 690 capsules

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
96764
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
RemedyRePack Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Within U.S - PA, VA, FL.
Product Description About Product Description
Full technical description of the product.
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

Batch or Lot Expiration Information

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