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 III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
What was recalled
TEV-TROPIN (somatropin (rDNA origin) for injection) 5 mg (15 IU). Prescription Only. Distributed By: TEVA Biologics & Specialty Products Division of Teva Pharmaceuticals USA, Sellersville, PA 18960 Manufactured in Israel.
- Recalling firm
- Ferring Pharmaceuticals Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-240-2013
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 II · Moderate risk Terminated
Tev-Tropin
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.
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