# FDA recall D-1385-2014

> **Ferring Pharmaceuticals Inc** · Class II · drug recall initiated 2014-04-28.

## 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.

## Distribution

PA

## Key facts

- **Recall number:** D-1385-2014
- **Recalling firm:** Ferring Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-28
- **Report date:** 2014-06-25
- **Termination date:** 2015-08-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Parsippany, NJ, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall D-1385-2014. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1385-2014. Source: US FDA. Licensed CC0.

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