Cefixime Capsule
FDA Recall NDC 67877-584
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 Cefixime (NDC 67877-584). A significant event, classified as Class II, was initiated on Dec 21, 2021 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed impurities/degradation specifications"
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
December 2021 Class II Recall: Failed impurities/degradation specifications
Recall Number
Class II Terminated
Failed impurities/degradation specifications
Dec 21, 2021
Jan 12, 2022
42,698 bottles
Recall Profile & Regulatory Data
Event ID
89259
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Apr 13, 2023
Product Description
Cefixime Capsules, 400 mg, 50-count bottles, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ, NDC 67877-584-50
Batch or Lot Expiration Information
Lot# : 20140293, Exp Dec 2021; 20141525, 20141526, 20141527, Exp Mar 2022; 20143019, 20143020, 20143021, 20143022, Exp July 2022; 20144759, 20144760, 20144761, Exp Nov 22
Affected Packages Involved in this Recall
67877-584-50Product
67877-584-01Product
67877-584-05Product
67877-584-33Product
November 2021 Class II Recall: Failed Impurities/Degradation Specifications
Recall Number
Class II Terminated
Failed Impurities/Degradation Specifications
Nov 03, 2021
Nov 17, 2021
4104 bottles
Recall Profile & Regulatory Data
Event ID
88982
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 21, 2022
Product Description
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
Batch or Lot Expiration Information
Lot# Lot 20140282, exp Dec 2021
Affected Packages Involved in this Recall
67877-584-50Product
67877-584-01Product
67877-584-05Product
67877-584-33Product
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.
