Home / Recalls / Ferring Pharmaceuticals Inc / D-1385-2014

D-1385-2014 Class II Terminated

Recalled by Ferring Pharmaceuticals Inc — Parsippany, NJ

Recall Details

Product Type
Drugs
Report Date
June 25, 2014
Initiation Date
April 28, 2014
Termination Date
August 6, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
129,060 cartons

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

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.

Distribution Pattern

PA

Code Information

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

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  • D-1426-2014 Class III — ENDOMETRIN (progesterone) Vaginal Insert 100 mg USP, 21 inserts, Rx Only, Manufa (September 19, 2013)
  • D-240-2013 Class III — TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription (February 1, 2013)