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 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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
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.
Drug: Somatropin
- Recalling firm
- Ferring Pharmaceuticals Inc
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-240-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 II · Moderate risk
Tev-Tropin
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.
Other recalls by Ferring Pharmaceuticals Inc
All 2013 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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