FDAClass IIJune 2, 2021

Benztropine Mesylate Tablets recall: CGMP Deviations

Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811

Why was Benztropine Mesylate 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?

S2008031

Product
Benztropine Mesylate Tablets, USP in all pack sizes, styles and strengths Manufactured for: Qualitest Pharmaceuticals Huntsville, AL 35811
Recalling firm
Cardinal Health Inc.
Quantity
60 bottles
Distribution
FL, GA, SC
Recall date
June 2, 2021
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls