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Tacrolimus

FDA recalls

7 rows

DateCompany and reasonClass
Dec 22, 2024Astellas Pharma US Inc.
Failed Tablet/Capsule Specifications: Bottles shipped to the USA may contain empty capsules		Class I · Ongoing
Dec 14, 2023Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.		Class II · Terminated
Feb 7, 2023Dr. Reddy's Laboratories, Inc.
Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.		Class II · Ongoing
Jul 10, 2022Glenmark Pharmaceuticals Inc., USA
Defective Container: Tube split from side seam		Class III · Ongoing
Dec 21, 2020Strides Pharma Inc.
Failed Moisture Limits		Class III · Terminated
Mar 22, 2020Mylan Pharmaceuticals Inc.
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.		Class III · Terminated
Jun 28, 2012Mylan LLC.
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.		Class II · Terminated

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Sources: CMS Medicare Part D Prescribers 2024; CMS Open Payments 2025 (general payments; a payment is not evidence of wrongdoing); FDA enforcement reports (openFDA).