FDAClass IIIJuly 11, 2012

Loxitane Capsules recall: Labeling Error

Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01

Why was Loxitane Capsules recalled?

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

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?

Lot # 22478A

Product
Loxitane Capsules, Loxapine Succinate Capsules, 10mg base, 100 count bottle, Rx only, Watson Laboratories Inc., Corona, CA 92880 NDC # 52544-495-01
Recalling firm
Watson Laboratories Inc
Quantity
7,262 bottles
Distribution
Nationwide.
Recall date
July 11, 2012
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls