Tacrolimus Capsule
FDA Recall NDC 64380-721
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Tacrolimus (NDC 64380-721). A significant event, classified as Class III, was initiated on Dec 22, 2020 by Strides Pharma Science Limited. The reported reason for this action was: "Failed Moisture Limits"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
Failed Moisture Limits
Dec 22, 2020
Jan 06, 2021
960 bottles
Recall Profile & Regulatory Data
Event ID
87027
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Strides Pharma Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
PA
Termination Date
Jan 26, 2022
Product Description
NDC 64380-721-06 TACROLIMUS CAPSULES, USP 1mg 100 Capsules Rx Only Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816
Batch or Lot Expiration Information
Lot# Lot 7242728A; June 2023
Affected Packages Involved in this Recall
64380-720-06Product
64380-720-01Product
64380-721-06Product
64380-721-01Product
64380-722-01Product
64380-722-06Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
