PRAVASTATIN SODIUM

Generic: PRAVASTATIN SODIUM

Aurobindo Pharma LimitedManufacturer
ORALRoute
PRAVASTATIN SODIUMActive Substance
2017-02-02Original Approval

PRAVASTATIN SODIUM is FDA application ANDA203367, sponsored by AUROBINDO PHARMA. 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 II2025-03-13
Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx o

CGMP Deviations

Class II2023-02-07
Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2023-02-07
Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NC

CGMP Deviations: recalling drug products following an FDA inspection.

Class II2019-03-25
Pravastatin Sodium Tablets USP, 20 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No

Presence Of Foreign Tablet: in a bottle of Pravastatin Sodium Tablets 20 mg.

Class III2017-07-11
Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC

Failed Impurities/Degradation Specifications: high out of specification results for related impurity

Class II2025-03-13
Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,

CGMP Deviations

Class II2017-11-17
Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimo

Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint

Class III2013-04-05
Glenmark Pravastatin Sodium Tablets ,40 mg, 90-count bottle (NDC 68462-197-90), Rx only, Manufactured by Glenmark Generi

Chemical Contamination: Pravastatin Sodium Tablets isbeing recalled due to complaints related to an

Class II2024-06-28
Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1

Failed Dissolution Specifications: results below specifications

Class II2023-02-07
Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; b

CGMP Deviations: recalling drug products following an FDA inspection.

Top Reported Reactions

1
FATIGUE
1,338 reports
2
DIARRHOEA
1,172 reports
3
NAUSEA
999 reports
4
DYSPNOEA
984 reports
5
HEADACHE
901 reports
6
DRUG INEFFECTIVE
879 reports
7
FALL
868 reports
8
DIZZINESS
789 reports
9
ARTHRALGIA
735 reports
10
ASTHENIA
727 reports