FDA-Drug2014-06-25Class II

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

Ferring Pharmaceuticals Inc
Hazard

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.

Sold states
PA
Affected count
129,060 cartons
Manufactured in
4 Gatehall Dr Fl 3rd, N/A, Parsippany, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1385-2014

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