Drug Enforcement D-0139-2024

Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

Status

Ongoing

Classification

Class II

Report Date

December 13, 2023

Termination Date

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Product Information

Product description
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun-248 197 Uttarakhand, India Distributed By: Padagis, Allegan, MI 49010. NDC: 0574-0118-30
Product quantity
7,032 bottles
Reason for recall
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Padagis US LLC
Address
3940 Quebec Ave N

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

Recall number
D-0139-2024
Event ID
93345
Recall initiation date
November 1, 2023
Center classification date
December 5, 2023
Code info
Lot: 231104, 231105, 231106, exp 7/31/2025
More code info
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