D-1400-2012 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
- 106,323 bottles
Product Description
Loxapine Capsules USP, 10mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 Rx only. NDC # 0591-0370-01
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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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 #s: 107886A, 107887A, 112874A, 144274A, 196483A, 201146A, 217265A, 260747B, 283308A, 313279A, 313279B, 327892A, 327893A, 327894A, 387239A, 387240A, 427259A, 427260A, 456251A.