REGULATORY INTELLIGENCE·Recall
FDA Class II Recall: Teva's Granix (tbo-filgrastim) Pulled Due to Stability Failure
Teva Pharmaceuticals USA, Inc. initiated a Class II recall of 34,636 cartons of Granix (tbo-filgrastim) Injection due to failed 12-month stability tests, with a known peptide below specification limits. This voluntary, nationwide recall impacts supply chains for a critical leukocyte growth factor, necessitating immediate action from procurement and regulatory teams to manage disruption and ensure patient safety.
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