Drug 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
D-1385-2014
Product summary
- Event
- Event 68407
- Status
- Terminated
- Classification
- Class II
- Quantity
- 129,060 cartons
- Official record key
drug-enforcement:D-1385-2014
Official wording
Reason: 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.
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
Distribution pattern: PA
Derived failure modes
-
Foreign material or chemical contamination
Chemical Contamination