Anastrozole Tablet, Coated
FDA Recall NDC 68001-155
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 Anastrozole (NDC 68001-155). A significant event, classified as Class II, was initiated on May 09, 2019 by Bluepoint Laboratories. The reported reason for this action was: "GMP Deviations: Potential cross contamination due to cleaning procedure 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
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
May 09, 2019
Jul 17, 2019
375,921 bottles
Recall Profile & Regulatory Data
Event ID
83290
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide USA
Termination Date
Sep 09, 2020
Product Description
Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories
Batch or Lot Expiration Information
Lot# Count, Lot, Expiry: [30-count bottle] Lots M711214, M711215, M711216, M711217, exp 8/31/2019; Lots M802198, M802199, exp 1/31/2020; Lots M805203, M805204, M805207, exp 3/31/2019; Lots M812455, exp 6/30/2020; Lot M815766, exp 9/30/2020; Lots M818633, M818634, exp 10/31/2020; Lots M819858, M819859, exp 11/30/2020 [1000-count bottle] Lot M711218, exp 8/31/2019; Lot M802197, exp 1/31/2020; Lots M805209, M805946, exp 3/31/2020; Lot M812456, exp 6/30/2020; Lots M815767, M818273, exp 9/30/2020; Lot M819857, exp 11/30/2020
Affected Packages Involved in this Recall
68001-155-04Product
68001-155-08Product
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.
