Drug Enforcement D-0411-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

May 14, 2025

Termination Date

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Product Information

Product description
Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
Product quantity
23 bottles/30 count- 690 capsules
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Within U.S - PA, VA, FL.

Location & Firm

Recalling firm
RemedyRepack Inc.
Address
625 Kolter Dr Ste 4, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0411-2025
Event ID
96764
Recall initiation date
April 22, 2025
Center classification date
May 6, 2025
Code info
Lot#: B3698036-033125, B3688703-032625, Exp.: 07/31/2026.
More code info
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