Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
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.
Reason Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Reason Defective Delivery System; may have a low frequency assembly fault which may result in pens block during the so-called "air shot" step
Reason Lack of Assurance of Sterility
Reason Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the…
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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