Anastrozole Tablets (American Health) – Cross Contamination (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
American Health Packaging
Lot Codes / Batch Numbers
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
Products Sold
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
American Health Packaging is recalling Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bot due to GMP Deviations: Potential cross contamination due to cleaning procedure failure.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
GMP Deviations: Potential cross contamination due to cleaning procedure failure.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026