ANASTROZOLE

Generic: ANASTROZOLE

Zydus Lifesciences LimitedManufacturer

ORALRoute

ANASTROZOLEActive Substance

2010-06-28Original Approval

ANASTROZOLE is FDA application ANDA078921, sponsored by ZYDUS PHARMS USA INC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-05-09

Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manuf

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

Class II2019-05-06

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Class II2019-05-09

Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American H

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

Class II2019-05-06

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distribut

CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.

Top Reported Reactions

1

FATIGUE

2,364 reports

2

NAUSEA

1,887 reports

3

DIARRHOEA

1,793 reports

4

ARTHRALGIA

1,575 reports

5

ALOPECIA

1,444 reports

6

HEADACHE

1,183 reports

7

DYSPNOEA

1,087 reports

8

MALIGNANT NEOPLASM PROGRESSION

1,051 reports

9

ASTHENIA

1,036 reports

10

DIZZINESS

1,033 reports