Tacrolimus Capsule
FDA Recall NDC 0781-2103
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 0781-2103). A significant event, classified as Class II, was initiated on Oct 22, 2013 by Sandoz Inc.. The reported reason for this action was: "Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin"
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 II Terminated
Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
Oct 22, 2013
Jan 01, 2014
12,521 bottles
Recall Profile & Regulatory Data
Event ID
66531
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sandoz Incorporated
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jul 10, 2014
Product Description
Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01
Batch or Lot Expiration Information
Lot# Lots DE9898, DE9900, DE9903, DE9908, DE9911. Exp. 06/14
Affected Packages Involved in this Recall
0781-2102-01Product
0781-2103-01Product
0781-2104-01Product
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.
