cGMP deviations: potential for Microbial Contamination of Non-Sterile Products
Ferring Pharmaceuticals
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
Failed pH specifications: Out of Specification pH results for 0.9% Sodium Chloride, USP
Superpotent Drug
Superpotent Drug
Superpotent Drug
Subpotent Drug
Discoloration; due to prolonged heat exposure.
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.
Labeling: Label Mix-up: Units of Lot 201131320087 are packaged in cartons labelled for Needle-Free Head B, but contaiin Needle-Free Head A
Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.