Category: FDA Updates
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Fresenius Kabi Issues Voluntary Nationwide Recall of Three Lots of Famotidine Injection
Fresenius Kabi has issued a voluntary nationwide recall of three lots of Famotidine Injection USP, 20 mg per 2 mL (10 mg/mL), after laboratory testing identified an out‑of‑specification impurity result in a single lot. The recall is precautionary and intended to protect patients and maintain supply-chain integrity while further investigations continue.1 Summary of the recall
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FDA Recall: Over 480K bottles of Teva’s Prazosin Hydrochloride
Teva Pharmaceuticals USA initiated a voluntary, nationwide recall of multiple lots of Prazosin Hydrochloride capsules after laboratory testing found levels of an N‑nitroso impurity (designated N‑nitroso Prazosin impurity C) above the FDA’s acceptable intake limit calculated using the Carcinogenic Potency Categorization Approach (CPCA). The agency classified the recall as Class II, indicating that use of