Enforcement Report - Week of August 8, 2012
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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. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| 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. | Lot #s: 412572A, 412572B, Exp 11/12 | Class III | Impurities/Degradation Products: High Out-of-specification results were obtained for both known and unknown impurities. | 18,938 cartons | D-1436-2012 |
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