drugs Class II Updated 2014-06-25

Ferring Pharmaceuticals Inc recalls TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Affected States: PA
Lot/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
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