TEV-TROPIN [somatropin — Class II drug recall D-1385-2014
Terminated recall by Ferring Pharmaceuticals Inc, reported 2014-06-25, distributed in PA. Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to le
| Recall number | D-1385-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ferring Pharmaceuticals Inc, Parsippany, NJ, United States |
| Recall initiated | 2014-04-28 |
| Classified | 2014-06-17 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2015-08-06 |
| Distributed | PA |
| Quantity | 129,060 cartons |
| Reason classes | chemical contamination, packaging |
| NDC | 57844-0713-46 |
| Lot numbers | 03/16, 05/16, 07/16, H11599A, H11599B, H12913A, H12913B, H12914A, H12914B, H13846A, H13846B |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1385-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.