FDAClass IIJune 2, 2021

Darifenacin Extended-release Tablets 15 mg 30 Tablets recall: CGMP Deviations

Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for…

Why was Darifenacin Extended-release Tablets 15 mg 30 Tablets recalled?

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

BDZ9G005

Product
Darifenacin Extended-release Tablets 15 mg 30 Tablets Rx only, Manufactured by: Torrent Pharmaceuticals, LTD Indrad-382 721, India Manufactured for…
Recalling firm
Cardinal Health Inc.
Quantity
37 bottles
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls