Enforcement Report - Week of July 11, 2012
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Product Detail
| Product Description | Loxapine Capsules USP, 25mg, 100 count bottle, Rx only, Manufactured By: Watson Laboratories Inc., Corona, CA 92880 NDC # 0591-0371-01 |
|---|---|
| Recall Number | D-1401-2012 |
| Classification | Class III |
| Code Info | Lot #s: 101696A, 110829A, 123685A, 123687A |
| Product Distributed Qty | 21,572 bottles |
| Reason For Recall | Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged. |
Event Detail
| Event Id | 62383 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Watson Laboratories Inc |
| City | Corona |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-04-17 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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