Anastrozole Tablet, Coated
FDA Recall NDC 60687-112
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 60687-112). A significant event, classified as Class II, was initiated on May 09, 2019 by American Health Packaging. 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
Jun 26, 2019
15,386 cartons
Recall Profile & Regulatory Data
Event ID
82854
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
American Health Packaging
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the USA
Termination Date
Sep 30, 2020
Product Description
Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.
Batch or Lot Expiration Information
Lot# : 175289A, 175286B, 175290B, Exp. 08/31/2019; 179906A, Exp. 03/31/2020; 183252A, Exp. 09/30/2020; 184611A, Exp. 11/30/2020
Affected Packages Involved in this Recall
60687-112-11Product
60687-112-21Product
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.
