REGULATORY INTELLIGENCE·Warning Letter
FDA Recall: B & B Pharmaceuticals' Estradiol Contaminated with Teflon, Highlighting cGMP Lapses
B & B Pharmaceuticals, Inc. initiated a nationwide Class II recall of Estradiol, USP (Non-Micronized) (Hemihydrate) due to Teflon contamination introduced during production. This event underscores critical cGMP deviations impacting product integrity and patient safety. Procurement and regulatory teams must reassess supplier qualification and supply chain vigilance to mitigate risks associated with active pharmaceutical ingredient (API) quality failures.
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