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U.S. Department of Health and Human Services

Enforcement Report - Week of June 25, 2014

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Product Detail

Product Description TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46
Recall Number D-1385-2014
Classification Class II
Code Info Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16
Product Distributed Qty 129,060 cartons
Reason For Recall Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.

Event Detail

Event Id 68407
Product Type Drugs
Status Ongoing
Recalling Firm Ferring Pharmaceuticals Inc
City Parsippany
State NJ
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-28
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide.