Drug Enforcement D-0454-2025

cGMP deviations

Status

Ongoing

Classification

Class II

Report Date

June 11, 2025

Termination Date

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Product Information

Product description
Indomethacin Extended-Release Capsules, USP, 75 mg, 30 capsules (3 x 10 blister cards) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-411-21 (carton), NDC 68084-411-11 (blister card).
Product quantity
21 cartons
Reason for recall
cGMP deviations
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Amerisource Health Services LLC
Address
2550 John Glenn Ave Ste A, N/A

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

Codes & Dates

Recall number
D-0454-2025
Event ID
96898
Recall initiation date
May 15, 2025
Center classification date
June 2, 2025
Code info
Lot #: 1021950, Exp. 11/30/2026
More code info
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