Anastrozole Tablet, Coated
FDA Recall NDC 68382-209
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 Anastrozole (NDC 68382-209). A significant event, classified as Class II, was initiated on May 06, 2019 by Zydus Pharmaceuticals Usa Inc.. The reported reason for this action was: "CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure."
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
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
768 1000-count bottles
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10
Batch or Lot Expiration Information
Lot# Lot EXP Date: M708570 Jun-19, M711270 Sep-19, M802207 Feb-20, M812460 Aug-20
Affected Packages Involved in this Recall
68382-209-06Product
68382-209-10Product
Class II Terminated
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
May 06, 2019
Jun 26, 2019
1,425,264 30-count bottles
Recall Profile & Regulatory Data
Event ID
82827
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Zydus Pharmaceuticals USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Sep 16, 2021
Product Description
ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06
Batch or Lot Expiration Information
Lot# Lot: M706674, M706676, M707685 EXP Jun-19; M711219, M711220, M711221, M711222, M711269, EXP Sep-19; M801027, EXP Dec-19; M801028, M801029, M801030, EXP Jan-20; M802206, EXP Feb-20, M805195, M805196, M805197, EXP Mar-20; M805199, M805202, M805944, M805945, M805948, M805951, M805953, M805956, M805957, M805958, M805959 Apr-20; M812457, EXP Jul-20, M812458, M812459, M813912, M813913, M813914, M813915, M813916, EXP Aug-20; M815768, M815769, M818274, EXP Oct-20; M818119, M818120, M818121, M818635, EXP Nov-20; M819270, M819861, M819862, EXP Dec-20; M900921, M900922, M900923, M900924, M900925, EXP Jan-21; M902634, M902635, EXP Feb-21.
Affected Packages Involved in this Recall
68382-209-06Product
68382-209-10Product
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.
