Drug Enforcement D-1399-2012

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

Status

Terminated

Classification

Class III

Report Date

July 11, 2012

Termination Date

March 18, 2013

Product Information

Product description
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Product quantity
8254 bottles
Reason for recall
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide.

Location & Firm

Recalling firm
Watson Laboratories Inc
Address
311 Bonnie Cir, N/A

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

Codes & Dates

Recall number
D-1399-2012
Event ID
62383
Recall initiation date
April 17, 2012
Center classification date
June 29, 2012
Code info
Lot 108094A
More code info
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