Posaconazole Tablet, Delayed Release
FDA Recall NDC 70377-038
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 Posaconazole (NDC 70377-038). A significant event, classified as Class II, was initiated on Jan 31, 2023 by Biocon Phama Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: High Out Of Specification degradation results."
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
January 2023 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.
Jan 31, 2023
Feb 15, 2023
3665 bottles
Recall Profile & Regulatory Data
Event ID
91577
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
BIOCON PHARMA INC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Jun 21, 2024
Product Description
Posaconazole Delayed-Release Tablets, 100 mg, 60-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009; Manufactured by: Biocon Pharma Limited, Bengaluru, India - 560 099, NDC 70377-038-11.
Batch or Lot Expiration Information
Lot# : BF21003163, BF21003246, BF21003161, Exp. Sep-2023; BF21004742, Exp. Dec-2023; BF22003359, Exp. Sep-2025
Affected Packages Involved in this Recall
70377-038-11Product
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.
