Enforcement Report - Week of August 8, 2012
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Product Detail
| Product Description | Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA 92880; Distributed by: Watson Pharma, Inc., Corona, CA 92880. |
|---|---|
| Recall Number | D-1436-2012 |
| Classification | Class III |
| Code Info | Lot #s: 412572A, 412572B, Exp 11/12 |
| Product Distributed Qty | 18,938 cartons |
| Reason For Recall | Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities. |
Event Detail
| Event Id | 62407 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Watson Laboratories Inc |
| City | Corona |
| State | CA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-06-05 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide. |
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