Drug Enforcement D-0445-2025

cGMP deviations

Status

Ongoing

Classification

Class II

Report Date

May 28, 2025

Termination Date

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Product Information

Product description
Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-016-01.
Product quantity
9107 bottles
Reason for recall
cGMP deviations
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
Nationwide

Location & Firm

Recalling firm
KVK Tech, Inc.
Address
110 Terry Dr, N/A

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

Recall number
D-0445-2025
Event ID
96847
Recall initiation date
May 9, 2025
Center classification date
May 21, 2025
Code info
Lot#: 18400A, Exp 7/31/2027
More code info
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