November 2023 FDA Recall Trospium Chloride by Padagis Us Llc
D-0139-2024 - Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules

This Class II drug recall was voluntarily initiated by Padagis Us Llc on November 1, 2023 for the product Trospium Chloride. The FDA reported the reason for recall as failed tablets/capsules specifications; missing/broken/extra tablets within the capsules. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0139-2024

Reason for Recall
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Initiated
11-01-2023
Reported
12-13-2023
Quantity
7,032 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93345
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Padagis US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# Lot: 231104, 231105, 231106, exp 7/31/2025

Affected Packages Involved in this Recall

0574-0118-30 Trospium Chloride Er