ATORVASTATIN CALCIUM

Generic: ATORVASTATIN CALCIUM

Cadila Pharmaceuticals LimitedManufacturer
ORALRoute
ATORVASTATIN CALCIUM TRIHYDRATEActive Substance
2023-10-16Original Approval

ATORVASTATIN CALCIUM is FDA application ANDA212103, sponsored by CADILA PHARMS LTD. 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 II2012-11-09
Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jac

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may c

Class II2023-02-07
Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2025-09-19
Atorvastatin Calcium Tablets USP, 80 mg, Rx Only, a). 90-count(NDC 67877-514-90), b). 500-count(NDC 67877-514-05), Manuf

Failed Dissolution Specifications

Class III2015-05-06
Amlodipine besylate and Atorvastatin calcium tablets, 5mg/10mg, packaged in a)30-count bottle (NDC 43598-322-30), b) 90-

Subpotent drug

Class III2022-03-16
Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 53

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.

Class III2018-01-29
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd

Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degra

Class III2018-06-12
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 5511

Failed Impurities/Degradation Specifications

Class III2018-06-12
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam -

Failed Impurities/Degradation Specifications

Class II2017-03-20
Atorvastatin Calcium Tablets, 10 mg*, packaged in a) 90-count bottles (NDC 0378-3950-77); b) 90-count bottles (NDC 0378-

Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identificat

Class II2023-02-07
Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,00

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
FATIGUE
4,651 reports
2
DRUG INEFFECTIVE
4,376 reports
3
DIARRHOEA
4,103 reports
4
NAUSEA
3,790 reports
5
DYSPNOEA
3,773 reports
6
HEADACHE
3,435 reports
7
DIZZINESS
3,039 reports
8
PAIN
2,889 reports
9
OFF LABEL USE
2,834 reports
10
COUGH
2,641 reports