Drug Enforcement D-0378-2025

CGMP Deviations

Status

Ongoing

Classification

Class II

Report Date

April 30, 2025

Termination Date

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Product Information

Product description
Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00
Product quantity
1,858 30-count blister cards
Reason for recall
CGMP Deviations
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
PA

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0378-2025
Event ID
96627
Recall initiation date
March 24, 2025
Center classification date
April 18, 2025
Code info
Lot J0826722-121624 Exp. 12/31/2025 Lot J0820365-111324 Exp. 11/30/2025 Lot J0814691-101624 Exp. 10/31/2025
More code info
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