Class II · Moderate risk
ZOMA-Jet 10 Demonstration Kit
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.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
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
Affected NDC
57844-0713-46
Compare with the code on your package — it is the most precise check available.
Drug: Somatropin
- 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 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Somatropin recalls
See all
Class II · Moderate risk
ZOMA-Jet 5 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
Norditropin FlexPro Somatropin
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
Tev-Tropin
Lack of Assurance of Sterility
Class III · Low risk
Tev-Tropin
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Other recalls by Ferring Pharmaceuticals Inc
All 2014 recalls
Class II · Moderate risk
Endometrin
cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Class II · Moderate risk
ZOMA-Jet 10 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class II · Moderate risk
ZOMA-Jet 5 Demonstration Kit
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Class III · Low risk
Menopur 75 IU
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
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