FDAClass IIJuly 17, 2019

Anastrozole Tablets recall: Contamination

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…

Why was Anastrozole Tablets recalled?

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
American Health Packaging
Quantity
375,921 bottles
Distribution
Nationwide USA
Recall date
July 17, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls