Enforcement Report - Week of March 20, 2013
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Product Detail
| Product Description | Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960. |
|---|---|
| Recall Number | D-193-2013 |
| Classification | Class II |
| Code Info | Lot # N03029, Exp 03/14 |
| Product Distributed Qty | 3,913 bottles |
| Reason For Recall | Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle. |
Event Detail
| Event Id | 64233 |
|---|---|
| Product Type | Drugs |
| Status | Ongoing |
| Recalling Firm | Teva Pharmaceuticals USA, Inc. |
| City | Sellersville |
| State | PA | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2013-01-23 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Nationwide |
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