Class II · Moderate risk Terminated
ZOMA-Jet 10 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Tev-Tropin
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
What was recalled
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
- Recalling firm
- Ferring Pharmaceuticals Inc
- NDC code
- 57844-713-46
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1385-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Somatropin recalls
See all
Class II · Moderate risk Terminated
ZOMA-Jet 5 Demonstration Kit
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk Terminated
Norditropin FlexPro Somatropin
Reason Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Class II · Moderate risk Terminated
Tev-Tropin
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Tev-Tropin
Reason Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
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