Tacrolimus Capsule
FDA Recall NDC 0378-2045
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tacrolimus (NDC 0378-2045). A significant event, classified as Class III, was initiated on Mar 23, 2020 by Mylan Pharmaceuticals Inc.. The reported reason for this action was: "Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles."
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
March 2020 Class III Recall: Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Recall Number
Class III Terminated
Presence of foreign tablet/capsule - Potential presence of commingled one Tacrolimus 1 mg capsule in 5 mg bottles.
Mar 23, 2020
Apr 01, 2020
3,816 botlles
Recall Profile & Regulatory Data
Event ID
85273
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Mylan Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Jul 07, 2021
Product Description
Tacrolimus Capsules, USP 5mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2047-01
Batch or Lot Expiration Information
Lot# 3105410, 3106268, Exp 9/2020
Affected Packages Involved in this Recall
0378-2045-01Product
0378-2046-01Product
0378-2047-01Product
Class II Terminated
Failed USP Content Uniformity Requirements: OOS result reported on retained samples.
Jun 29, 2012
Dec 05, 2012
15181 bottles.
Recall Profile & Regulatory Data
Event ID
62454
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mylan LLC.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Natiowide
Termination Date
Apr 13, 2017
Product Description
Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01
Batch or Lot Expiration Information
Lot# Lots: 3027684 Exp. 5/13, 3027688 Exp. 6/13 2002157 Exp. 9/12
Affected Packages Involved in this Recall
0378-2045-01Product
0378-2046-01Product
0378-2047-01Product
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.
