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

FDA recall notice · announced June 25, 2014 · Ferring Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

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.

Notes

Distribution: PA
Lot/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
Quantity: 129,060 cartons
Status: Terminated
Products in this recall event:
- 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 (D-1385-2014)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.