Drug Enforcement D-0304-2025

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

Status

Ongoing

Classification

Class III

Report Date

April 9, 2025

Termination Date

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Product Information

Product description
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.
Product quantity
224 cartons
Reason for recall
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Address
341 Mason Rd

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

Codes & Dates

Recall number
D-0304-2025
Event ID
96416
Recall initiation date
March 4, 2025
Center classification date
March 28, 2025
Code info
Lot# T05393, Exp. Date: 09/30/2025
More code info
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