D-1399-2012 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 11, 2012
- Initiation Date
- April 17, 2012
- Termination Date
- March 18, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8254 bottles
Product Description
Loxapine Capsules USP, 5mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 00591-0369-01.
Reason for Recall
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Distribution Pattern
Nationwide.
Code Information
Lot 108094A