Status
Terminated
Drug Enforcement D-1402-2012
Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.
Classification
Class III
Report Date
July 11, 2012
Termination Date
March 18, 2013
Product Information
- Product description
- Loxapine Capsules USP, 50mg, 100 count bottle, Rx only Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0372-01
- Product quantity
- 18,902 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- Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.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-1402-2012
- Event ID
- 62383
- Recall initiation date
- April 17, 2012
- Center classification date
- June 29, 2012
- Code info
- Lot #s: 104432A, 104433A, 121344A, 127024A, 144290A
- More code info
- —