ESOMEPRAZOLE MAGNESIUM

Generic: ESOMEPRAZOLE MAGNESIUM

NorthStar Rx LLCManufacturer

ORALRoute

ESOMEPRAZOLE MAGNESIUMActive Substance

2015-09-25Original Approval

ESOMEPRAZOLE MAGNESIUM is FDA application ANDA078279, sponsored by DR REDDYS. 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 III2022-06-21

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laborat

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Class III2022-06-21

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Labora

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

Class II2020-12-17

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theop

Class II2025-05-13

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg, 30-count single dose packets per carton, Rx Only, Man

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ind

Class II2020-12-17

Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theop

Class III2024-11-14

Esomeprazole Magnesium for Delayed-Release Oral Suspension 40 mg, 30 Single-Dose Packets, Rx Only, Manufactured by: Zydu

Labeling: Not Elsewhere Classified - Wrong NDC number

Class III2020-04-24

Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laborato

Discoloration: product contains brown pellets

Class III2023-10-23

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-c

Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of or

Class III2019-02-06

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (

Discoloration: Esomeprazole Magnesium DR Capsules (40mg) may contain brown pellets.

Class II2025-05-13

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 40 mg, 30-count Single-Dose Packets per carton, Rx Only, Man

Failed Impurities/Degradation Specifications: Out-of-Specification test results obtained for any ind

ESOMEPRAZOLE MAGNESIUM

Recalls

Top Reported Reactions