D-1401-2012 Class III Terminated
FDA drug recall D-1401-2012 was initiated by Watson Laboratories Inc on April 17, 2012 and is designated Class III. Reason for recall: Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. The recall status is terminated (terminated March 18, 2013). Affected quantity: 21,572 bottles.
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
- 21,572 bottles
Product Description
Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01
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Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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: 101696A, 110829A, 123685A, 123687A