Pharmacy Learning Network

Key Takeaways: The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for estradiol gel, 0.1%, 0.25 mg. The affected batch has been identified as Lot 245226005B (expiring April 2028), containing 2592 cartons. The recall was initiated by Amneal Pharmaceuticals, LLC due to a defective container, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

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Key Takeaways: The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Zoladex (goserelin) implant, 3.6 mg. The affected batch has been identified as Lot YN0099 (expires January 2028), containing 296 cartons. The recall was initiated by TerSera Therapeutics, LLC due to improper temperature regulation, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.

Key Takeaways Medicare Advantage coding accuracy remains a federal enforcement focus. The settlement centers on allegations that inaccurate or unsupported diagnosis codes were not investigated and deleted in a timely manner, affecting risk-adjusted Medicare Advantage payments. Corrective action can factor into False Claims Act resolutions.

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Key Takeaways: The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for Menow sunscreen pressed powder, SPF35, PA+++, 9 g/0.32 oz. The affected batch has been identified as Lot 2024/10/11 (expires October 2027), containing 2970 units.

Key Takeaways: The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for exenatide injection, USP, 250 mcg/mL. The affected batch has been identified as Lot AP250095A (expires February 2027), containing 5694 pens.

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Key Takeaways: The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for chlorthalidone tablets, USP, 25 mg. The affected batch has been identified as Lot RISA24002 (expires April 2027), containing 13 567 bottles.

Key Takeaways: The US Food and Drug Administration (FDA) has issued a voluntary Class II recall for dopamine hydrochloride injection, USP, 40 mg/mL. The affected batch has been identified as Lot NL5230 (expiring October 2027). The recall was initiated by Pfizer due to a lack of sterility assurance, a quality issue that is likely to cause temporary or medically reversible adverse health consequences or has a low probability of serious adverse health consequences.